₁Executive summary: Human embryonic stem cell (hESC) research and human cloning research are immoral. Research involving embryonic-like stem cells, also called induced pluripotency stem cells or iPS cells, has been termed ethical because it does not involve harvesting stem cells from an embryo, but rather reprograms skins cells back to the more primitive state of stem cells. However, to achieve clinically useful therapies, researchers studying human embryonic stem cells as well as iPS cells, at some point will have to turn to cloning to realize their goal of organ or tissue transplants. Human organ farms or factories would be the result. This means sacrificing one human life to cure another. Embryonic stem cell "lines" are in existence now, are a prototype of these farms, and represent the industrialization and instrumentalization of human beings. To fund this research, the regenerative medical establishment is creating a false sense of hope, saying that progress is being limited by ethical constraints, when in fact it is their own inability to date to create organs or tissue that can be used for transplants. Nor can they create human clones. Not only is hESC and human cloning research immoral and at a dead end, but it is diverting funds away from the ethical and promising field of adult stem cell research. A moratorium should be placed on research involving human embryonic stem cells and human cloning.

Stem cell laboratory

₂Editor's note: This series is intended as an exposé of the embryonic stem cell research industry. It is the opinion of this author that the highly educated research scientists in regenerative medicine are using their level of learning to pull the wool over the eyes of the general public by advancing the advantages of stem cell research as a cure for numerous diseases and injuries, cloaking in technical language the fact that their research is taking the lives of human beings and to date has provided no cures. This article is a series of three that will attempt to demystify stem cell research.

There are five chapters to Part I of this series of about 10 pages each. Initial subscript numbers in red roughly correspond to page numbers in print--see Executive Summary above as example.

Table of Contents
1. Baby, its you and you and you
2. Hello, stem cells
3. Key problem differentiation
4. All roads lead to cloning
5. Hello, Frankenstein

1. Baby, its you and you and you

Someday could we be growing clones of ourselves so as to harvest bodily organs to replace, say, our ailing heart or liver?

Stem cells in containers

₃Scientists have either developed or are in the process of developing artificial human embryos, eggs, sperm, ovaries and wombs--artificial in that they have been manipulated in the laboratory from stem cells or other bodily tissue. Almost as if by magic, they can now take ordinary skin cells and turn them into clones, exact copies of the creature from which the skin cells were taken. Billions of dollars are being expended to grow organs and tissue that can be transplanted in the quest to cure disease and replace failing organs via stem cell therapies.

With the tremendous advances being made in cloning and stem cell research, is the following account science fiction or the future of science?

Let us say that we have a President some time in the future, President John Doe. For national security reasons, it would obviously be in the national interest to have him in good health and optimally functioning.

Congress, let us say, passes the Presidential Cloning Act of 2020, authorizing the creation of a Presidential cloning bank. At the University of Wisconsin, famous for its stem cell technology, skin cells are taken from President Doe and regressed to become embryonic-like stem cells. Growth factors are added to these induced pluripotency stem cells, as they are called, to enable the clones to grow to adulthood in a few years. By means of somatic cell nuclear transfer, the cells are placed in ten donated human eggs.

These eggs are then electrically charged to artificially begin embryonic development and implanted in five women, who have agreed, for a government stipend, to carry these clonal embryos of the President to term. As a backup, five artificial wombs have been seeded with the five other clones.

₄Following birth nine months later, these clones (they all survived) are raised with the best of treatment to make sure they are healthy specimens, suitable some day for organ service, if the President so needed one. In the mean time, these Presidential clones live a good life, with the exception that they have few friends, primarily only medical staff at a place in which they reside called Clone Camp David. Sometimes the President plays basketball with the clones, although it is hard to tell who is who.

Let us say one day a medical exam of the President discloses that he needs a new heart. It is decided to sacrifice the most healthy, Clone 8. However, on learning of his fate, Presidential Clone No. 8 filed an injunction, saying that he is a person, and that surgically removing his heart would be murder.

The case is brought all the way to the U.S. Supreme Court, where it is adjudicated. The justices decided that it cannot be a murder, for Clone 8 is not a person by reason of Roe v. Wade. In the majority opinion, it was determined that since Roe. v. Wade held that "the unborn have never been recognized in the law as persons in the whole sense," mere passage of that non-person from the womb would not grant personhood. Further, the decision found that since Clone 8 was a mere copy of the President, copies are not persons, but merely clones, which do not count as human beings.

The majority opinion also found that since the President had donated his skin cells to the University of Wisconsin for the procedure and that since the patent for the cell line from which Clone No. 8 had been made was held by that university, ownership of the clone so created was also held by that institution.

Following signed permission by the university, Clone 8 was taken from Clone Camp David, strapped to an operating table at a secret location, anesthetized, his heart surgically removed, and transplanted into President John Doe, who recovered and thrived with his new heart. Clone 8 was buried in Arlington National Cemetery as a national hero.

Fiction or fact?
Science fiction or science future? The fact of the matter is we are headed in this direction, and in some instances, we are already there. As Steve Connor, a reporter for Britain's The Independent, observed: "one day we could all be growing our own set of organs ready to use should we need a transplant. But would it open the door to cloning humans?"

₅And the answer to that question is a definite yes. According to Stem Cells and the Future of Regenerative Medicine, a publication by National Academies Press and jointly authored by the nation's leading regenerative research groups (the Committee on the Biological and Biomedical Application of Stem Cell Research, the Board on Life Science, National Research Council, and the Board of Neuroscience and Behavioral Health, Institute of Medicine), their official recommendation is to pursue human cloning. The report states:

Recommendation: In conjunction with research on stem cell biology and the development of potential stem cell therapies, research on approaches that prevent immune rejection of stem cells and stem cell-derived tissues should be actively pursued. These scientific efforts include the use of a number of techniques to manipulate the genetic makeup of stem cells, including somatic cell nuclear transfer. (Stem Cells and the future of regenerative medicine, 2002, p. 59)

Somatic cell nuclear transfer (SCNT) is the technique that created the first animal clone, Dolly the sheep. Regenerative medicine's officially stated goal is to apply cloning to human beings.

Cloning is implicit in regenerative medicine's dream for growing whole organs and tissue that will not be rejected by a patient's immune system. Currently, in conventional medicine, when such organs as a heart or a liver are transplanted from a donor into the body of a patient, immunosuppressive drugs must be administered to prevent rejection, since the body identifies the new tissue as foreign and destroys it, just like the body attacks invading bacteria.

However, immunosuppressive drugs can cause the patient to develop a compromised immune system and have important limitations: death of the recipient from cardiovascular disease, infection, and cancer (Dantal, et al, 2005).

In theory, if a skin cell were taken from a patient and turned into a stem cell by means of SCNT, because the resultant stem cells were from the patient, no rejection would occur when the cells were transplanted for regenerative purposes.

But, two big problems face researchers: how to grow a human clone and when would be the best time to kill it to harvest the tissue or organs.

As a smoke screen for these goals, researchers use scientific terms such as "therapeutic cloning," "reproductive cloning," and "somatic cell nuclear transfer" so as to confuse and distract the public from the fact that their quest will end in killing people to cure other people. That is the pure and simple fact of the matter.

As theTime Magazine issue of February 19, 2001 stated in its cover story "Human cloning is closer than you think!: baby its you, and you and you":

"There is a significant gap between what scientists are willing to talk about in public and their private aspirations," says British futurist Patrick Dixon. "The law of genetics is that the work is always significantly further ahead than the news. In the digital world, everything is hyped because there are no moral issues--there is just media excitement. Gene technology creates so many ethical issues that scientists are scared stiff of a public reaction if the end results of their research are known."

Two important discoveries
₆Two recent discoveries in embryology have launched us down this road.

The blastocyst forms about 5 days after conception. The inner cells mass is extracted to obtain stem cells.

If left to grow, the trophoblast develops into the placenta, including the charion, and the inner cells mass starts to form the fetus.

Those two discoveries are:

1. how to extract and culture in the laboratory what are called stem cells, the inner cell mass of an embryo that contains all the genetic information needed to build a human being--organs and all, and

2. how to use the shell from which the inner cell mass has been extracted to function as the most magic of all rooms, namely, the discovery of how to take mere skin cells from an animal, and by placing them in this shell, called the trophoblast, turn those skin cells back into stem cells, then implanting that new embryo into a womb, creating an exact copy of the body from which the skin cells were taken--that is, creating a clone.

₇Following these discoveries, cloning and stem cell research have gone through a revolution, with breakthrough after breakthrough providing both scientific and ethical challenges as investigators progress down their paths of exploration, all hoping as they experiment that they can find ways to cure disease and repair organs.

There are two fronts in this battle: embryonic stem cells (hESCs) and adult stem cells.

While progress on both fronts is promising, advances in embryonic stem cells, as opposed to adult stem cells, come at a price--the destruction of human life. And it is not just the accidental loss of human life that is at stake, but the willful decision to take life to save life.

We can now grow vast quantities of embryonic stem cells in a laboratory for research purposes. Millions of stem cells in Petri dishes and other laboratory containers are being cultivated in universities and private research laboratories nationally and around the world, subjecting them to multitudes of research projects.

Stem cells are being studied because they have the capabilities of morphing into other types of body cells. They are sort of all-purpose cells. Within an embryo, stem cells can develop into any of the 210 cells types that compose the body to become a human being.

Extracted from the several-days-old embryo and grown in the laboratory, while possessing the potential for bodily development, the cells can not become different bodily parts, but instead endlessly replicate themselves, achieving an almost immortal status. Removed from their tightly programmed life as an embryo, like a broken record they just keep repeating the same genetic tune over and over (Healy, 2004).

However, given their vast quantities, they make ideal candidates for stem cell research. A research goal is to be able modify these stem cells in a test tube so as to treat a patient's disease or genetic defect and then in a laboratory setting, grow healthy tissue and organs for transplantation.

Adult stem cells, on the other hand, are found in bodily tissue after development of the embryo, such as in heart, bone marrow and other organs. Their function is to help repair the body, replenishing dying cells and regenerating damaged tissues. Adult stem cells are also called somatic stem cells, with "soma" in Greek meaning "body."

To date, no cures have been achieved with embryonic stem cells. When such cells are injected into animals experimentally, they are often either rejected by the animal's immune system or a tumor is created called a teratoma, consisting of a grotesque collection of unorganized bodily parts, such as teeth, hair and random cells (Healy, 2004).

Conversely, adult stem cells from bone marrow have been used to restore the immune system damaged by chemotherapy. Also, the clinical potential of adult stem cells has been demonstrated for such diseases as diabetes and kidney cancer. (FAQs, 2009)

Recently, the world's first tissue-engineered whole organ transplant--using a windpipe made with the patient's own stem cells--was carried out by surgeons from Spain. However, these stem cells were not embryonic stem cells. Instead, two types of cells were used--cells lining the patient's windpipe, and adult stem cells, very immature cells from the bone marrow, which were encouraged to grow into the cells that normally surround the windpipe (Roberts, 2008).

However, since adult stem cells present few, if any, ethical dilemmas, we will focus our discussion on embryonic stem cells.

₈To understand more clearly how we got to this point and where we are going, let us look more closely at recent developments in embryonic research.

Hello, Dolly
Until recently, fertilization of an egg by sperm was the only way to create an embryo. However, "Hello, Dolly."

On July 5, 1996 a lamb was born, cloned from the cells of a sheep's udder. Being cloned from part of a mammary gland, she was named "Dolly" after the famously busty country western singer Dolly Parton.

She became the first viable offspring ever derived from an adult mammalian cell, that is, a body cell, called a somatic cell, as opposed to conventional propagation from reproductive cells, called germs cells, such as egg and sperm cells (Henahan, 1997).

The procedure used was deceptively simple--the researchers removed an unfertilized egg cell from an adult ewe and replaced its nucleus, that is, its stem cells, with the nucleus of an adult sheep mammary gland cell. The nucleus contains the cell's genetic material. This modified egg was then implanted in another ewe.

For reasons that are not fully understood, the environment of the egg, which includes the trophoblast, reprogrammed the skin cell into stem cells. The outer wall of the egg surrounding the inner cells functions as a magic room, so to speak, converting the skin cells into stem cells. But its magic goes beyond even this. The embryonic shell does what scientists cannot do despite spending millions of dollars. It enables stem cells to differentiate. The magic of the embryo, that is, both the stem cells and the trophoblast working in combination, produce life--a living, separate, distinct being with organs essential for survival, like a heart, a brain, teeth, skin, nerves, hands, arms, legs.

In the sheep experiment, following the administration of an electrical shock, the embryo began to divide, and differentiate, eventually becoming a fetus and coming to term, producing Dolly, a copy or clone of the sheep from which the nucleus was originally extracted out of the udder cell. Both Dolly, and the donor "mother" ewe (not the ewe in which the embryo was implanted) were genetically the same, as sperm was not used for propagation, but simply cell replication.

But, questions begin to arise. Just what kind of a creature was Dolly? Was she any less of a sheep than the ewe from which her cell was derived? On material grounds, maybe, for she died relatively young for sheep, at the age of six, from progressive lung disease. Genetically, she was less viable than a sheep bred conventionally. But, by definition, as an animal, was she any less of a sheep, or, indeed, was she a sheep at all?

₉And what about the ethical considerations, when concerning possible human application? While an egg was not fertilized by sperm to create Dolly, an egg, nevertheless, was used and, in the process, destroyed by the removal of its nucleus.

An egg has the potential--having all the genetic information in the nucleus--of becoming a human being if united with sperm. Even by itself, an egg, theoretically, could be cloned using its own DNA through parthenogenesis, an asexual form of reproduction found in some female species, and possibly achievable in humans, where growth and development of embryos occurs without fertilization by a male.

But most importantly, in the human realm, would a human clone possess human rights of a citizen, or are they expendable, their lives designed to be instrumentalized for the healing of other?

With the first "baah" of Dolly the sheep, we enter a new world. To produce life now, no male is needed, plus one can reproduce an exact copy of another individual animal. And now, this technology is being directed toward human beings.

2. Hello, stem cells

For the first time, scientists had access to a cornucopia of undifferentiated cells that can grow into any one of the 200 or so cell types that make up a human being. That opened the door to remarkable possibilities, including replacement cells for malfunctioning pancreases, injured spinal cords and plaque-clogged brains.

First stem cell line created
₁₀Two years after Dolly appeared on the scene, the nation learned about stem cells. It all began back in 1998 when Science Magazine reported that a team lead by Dr. James A. Thomson of the Wisconsin Regional Primate Research Center, University of Wisconsin, Madison, had isolated stem cells from human embryos, incubating them for several months. "These cell lines should be useful in human developmental biology, drug discovery, and transplantation medicine," the research paper noted. (Thomson, 1998).

An embryonic stem cell line is a family of constantly dividing cells, the product of a group of stem cells. They are obtained from the nucleus of an embryo and can replicate for long periods of time in vitro ("within glass"; or, commonly, "in the lab", in an artificial environment).

Dr. James Thomson

What Thomson had done was to take embryos stored at a fertility clinic that had been donated by couples and using a microscopic pipette, sucked out the nucleus--the insides that contain the genetic information, the inner cell mass or DNA--and then placed those stem cells in feeder dishes lined with nutrients, growing them.

However, they did not grow into organs and tissue and limbs, but as mentioned, they just kept replicating themselves, just kept reproducing the genetic information, because without the whole embryo, the cells were unable to differentiate into specific types of tissue. But for the science of regenerative medicine, they provided valuable research opportunities. And the most critical goal was to find out just how to make them grow into usable organs and tissue in a laboratory environment, instead of in the environment of an embryo.

₁₁The discovery was greeted by praise and condemnation. Thomson was the subject of a Time Magazine cover story devoted to "America's best in science and medicine" and was described as "The man who brought you stem cells." As the August 20, 2001 article stated:

For the first time, scientists had access to a cornucopia of undifferentiated cells that can grow into any one of the 200 or so cell types that make up a human being. That opened the door to remarkable possibilities, including replacement cells for malfunctioning pancreases, injured spinal cords and plaque-clogged brains.

On the right is the natural development of cells from the blastocyst, the embryo, into specific cells, like heart and nerve cells, which together produce a human being. On the left, cells have been scooped out of the blastocyst and are cultured in a Petri dish. Researchers are attempting to go from cultured pluripotent stem cells to tissue-specific cells, skipping the natural growth of the blastocyst that occurs in the womb.

Embroiled in controversy
However, the cover story acknowledged that controversy surrounded this discovery, stating that:

It also brought stern warnings. Though the sacrificed embryos were no more than hollow, pinhead-size clusters of a few dozen cells, destroying them for whatever purpose represented, in the mind of many antiabortion conservatives, an assault on a human life (Cellular biology: stem winder, 2001).

The article failed to mention that this mere "hollow" ball of cells out of which the stem cells had been harvested provided the critically needed room or environment in which these stem cells, if they had been left in the embryo, could assemble themselves, grow and become a fetus and a human being. Without that embryonic shell, that is, limiting experiments to stem cells grown in the laboratory, despite a decade of research since the discovery, no differentiation into viable organs has been achieved, and thus no therapies.

Although viewed as having a potential to benefit mankind, stem cell research from its inception has been embroiled in controversy, with many questing its morality, since stem cells, when extracted from an embryo, prevent it from becoming a living organism, that is, a living person.

Countering the criticism, Louis M. Guenin, who teaches ethics at Harvard Medical School, believes that it is permissible to experiment on embryonic stem cells culled from an embryo that has not been used at a fertility clinic, categorizing it as an "epidosembryo" (after the Greek "epidosis," a benefit for the common good).

₁₂However, the Center for Bioethics and Human Dignity stated that embryonic stem cell research is at its very root and across the board unethical (An Overview of Stem Cell Research, 2010):

Many proponents of human embryonic stem cell research argue that it is actually wrong to protect the lives of a few unborn human beings if doing so will delay treatment for a much larger number of people who suffer from fatal or debilitating diseases. However, we are not free to pursue gain (financial, health-related, or otherwise) through immoral or unethical means such as the taking of innocent life (Deut. 27:25). The history of medical experimentation is filled with horrific examples of evil done in the name of science. We must not sacrifice one class of human beings (the embryonic) to benefit another (those suffering from serious illness). Scripture resoundingly rejects the temptation to "do evil that good may result" (Rom. 3:8).

Thomson himself had misgivings concerning embryonic stem cell research from the very beginning.

"If human embryonic stem cell research does not make you at least a little bit uncomfortable, you have not thought about it enough," he said. "I thought long and hard about whether I would do it."

In the end, he decided to go ahead, reasoning that the work was important and that he was using embryos from fertility clinics that would have been destroyed otherwise.

Promise of iPS cells
It was with a sigh of relief from both sides of the controversy that yet another stem cell breakthrough was reported, this one discovered by Thomson himself, as well as another researcher across the world, Dr. Shinya Yamanaka.

The New York Times reported in "Man Who Helped Start Stem Cell War May End It" that Thomson and Yamanaka had found a new way to turn ordinary human skin cells into what appear to be embryonic stem cells without ever using a human embryo. Thomson mused that with the new technique now--which involves adding just four genes to ordinary adult skin cells--it will not be long before the stem cell wars are a distant memory. "A decade from now, this will be just a funny historical footnote," he said (Kolata, 2007).

Dr. Yamanaka also had reservation about embryonic stem cell research. While peering through a microscope at a friend's fertility clinic, he recalled seeing what he thought could have easily been one of his own daughters.

When he made the social call, Dr. Yamanaka was an assistant professor of pharmacology, researching embryonic stem cells. At his friend's invitation he looked down the microscope at one of the human embryos stored at the clinic. What he viewed changed his scientific career.

"When I saw the embryo, I suddenly realized there was such a small difference between it and my daughters," he said. "I thought, we can't keep destroying embryos for our research. There must be another way."

₁₃After years of searching, Dr. Yamanaka, 45, a father of two and now a professor at the Institute for Integrated Cell-Material Sciences at Kyoto University, Japan, may have found "another way."

The announcement of these twin discoveries was hailed as a scientific and ethical breakthrough, touted as avoiding the destruction of human embryos for research and medical purposes.

By Thomson's and Yamanaka's method, laboratory-created stem cells, called variously "embryonic-like stem cells," "induced pluripotency stem cells," "iPS cells" or simply "iPSCs," are produced by a procedure called "cell regression." Skin cells are turned into embryonic-like stem cells by using viruses, instead of an embryo. The method does this by carrying genes into the skin cell, reprogramming its genetic structure to that of a stem cell. In essence, the process sets back its genetic clock, making it a more primitive, all purpose cell, that is, a stem cell.

And how did these cells get their name? "Pluripotent" means that these cells have the potential of developing into many different types of cells, namely, any one of the 210 cell-types in the human body, but that they are not "totipotent," that is, they can not go the next step and actually grow into different types of tissue and organs to become a human creature. This is because these cells are not the entire embryo, just the inside cell mass. They are called induced pluripotent stem cells because they have been induced or influenced to become pluripotent. Embryonic stem cells are simply pluripotent, while the entire embryo is totipotent.

Why iPS cells are important
IPSC technology is regarded as important because a major objective of researchers is to obtain stem cells that have the potential of developing into tissue or organs that will not be rejected due to a patient's immune response. Since iPS cells produce exact copies of a person's DNA, they could, in theory, produce tissue or organs that would not be rejected by the body's immune response.

One of the goals of regenerative medical researchers is to establish stem cell lines derived from patients.

Such cell lines have already been established at the Harvard Stem Cell Institute and the University of Wisconsin-Madison's WiCell Research Institute. At HSCI researchers have created iPS cell lines from patients with 10 different diseases, including Parkinson's Disease, Type I diabetes, Huntington's Disease, Down Syndrome, a form of combined immunodeficiency ("Bubble Boy's Disease"), and two forms of Muscular Dystrophy (Twenty Disease-Specific Stem Cell Lines Created, 2008). The WiCell Bank is offering three iPS cell lines, genetically reprogrammed from human skin cells to an embryonic state. According to Erik Forsberg, executive director of the WiCell Research Institute, "they represent the next generation of stem cell research" (Kelly, 2008).

These cells are in essence clones of the donor, but only genetically. Being pluripotent, not totipotent, they could not grow to become a person. Like the goal of embryonic stem cell research, a goal of iPSC research is to get the cells to skip becoming a fully developed person and yet grow into usable organs or tissue.

To get patient-specific cells suitable for transplantation, once skin cells have been turned back into all-purpose stem cells, they have to be coaxed in the laboratory into the specific kind of cells needed to form the tissue or organ to be transplanted. But that is turning out to be a big problem for researchers. Just as with embryonic stem cells, they can not successfully do it with iPS cells either, try as they might.

As with embryonic stem cells, iPSCs can not grow and differentiate due to the absence of the trophoblast--first, because this absence means they lack the ability to develop a placenta. This lack means they can not attach to the womb to receive nourishment and will die.

Secondly, without that outer shell, they can not differentiate into bodily organs that work. As mentioned, while pluripotent stem cells have the potential of developing into different specialized cells, without the trophoblast, the embryonic outer shell, they can not differentiate spontaneously with the same faithfulness as inside the embryo. While researchers using various methods can get them to head toward differentiation in a laboratory, they can not grow these cells into cells that can function to repair nerves, a hand, a heart or a brain.

Researchers switching to iPSCs
₁₄With the discovery of iPSC technology, researchers began to switch to this method for the study of stem cells.

An egg from which the inner mass, that is, stem cells, is being removed for cloning purposes.

Professor Ian Wilmut, Edinburgh University, the scientist who led the team that created Dolly the sheep, recently announced that he is abandoning the cloning of human embryos in stem cell research. Instead, he will use the method developed by Dr. Thomson and Yamanaka, that is, using iPSC technology.

"We've not made this decision because it's ethically better", Professor Wilmut said. "To me it's always been ethically acceptable to think that if you could use cells from a human embryo to develop a treatment for a disease like motor neurone disease, for which there is no treatment at present, then that is an acceptable thing to do (Dolly scientist abandons cloning, 2007)."

Instead, he said, it was being used for practical purposes, although he mentioned, that the Japanese approach is also "easier to accept socially (Lavin, 2007)."

iPSC development lauded
Because iPS cells have all the properties of embryonic stem cells, but are obtained from skin tissue without using embryos, this development was lauded by numerous pro-life groups, religious organizations and even former President George Bush, himself.

On learning of the breakthrough, President Bush said he was pleased to learn that scientists have reprogrammed skin cells into stem cells "within ethical boundaries."

Others echoed his praise of the procedure.

"Once again science is catching up to ethics, proving that the moral way is the most sound, scientific choice. This breakthrough allows scientists to further their research and continue to develop medical advances while still honoring the sanctity of life," said Wendy Wright, President of Concerned Women for America. "Policymakers can safely abandon the politically-charged demand to fund the destruction of embryos to find stem cell solutions."

All roads lead to cloning

₁₅Ethical perils of iPSC technology: But is this really the case? Does iPSC technology avoid violating the sanctity of life at all levels of stem cell research? And, can policymakers give up the fight to stop the federal and state funding of stem cell research because of the iPSC breakthrough?

The answer is no.

If researchers limited their investigation to treatment of disease states by experimenting on stem cells derived from persons using skin samples to create iPS cells, no ethical considerations would be involved, for no embryo would be destroyed. However, problems emerge when investigators attempt to find ways to coax cells to differentiate into specific tissue or organs that can be transplanted. Further, the hope of iPS cells has been tarnished by a new study published in the Proceedings of the National Academy of Sciences comparing the ability of induced cells and embryonic cells to morph into the cells of the brain. The study found that induced cells differentiate less efficiently and faithfully than their embryonic counterparts (Devitt, 2010).

Neither induced pluripotent nor embryonic stem cells as yet can be coaxed to differentiate for clinical use, that is, for the treatment of patients. These roadblocks are forcing scientists to take a detour and that detour is through the land of cloning. In fact, all roads lead to cloning. To find out why, we will look first more deeply into recent developments in stem cell research.

Stem cell research progress
A researcher either can attempt to grow such tissue in the laboratory as an isolated organ, that is, attempt to grow a live, pumping heart in a test tube-type environment or, instead, modify the genetic structure of the cells in the laboratory and then inject or graft these modified heart muscle cells into an ailing patient's heart to repair it.

Pictured here in a microscopic photo are early retinal cells (green) and early brain cells (blue).

₁₆Researchers are achieving some limited successes. Using embryonic stem cells and iPS cells, a team of scientists from the University of Wisconsin School of Medicine and Public Health have successfully grown multiple types of retina cells. Led by David Gamm, assistant professor of ophthalmology and visual science, and Jason Meyer, research scientist, they said that the advance could serve as a foundation for unlocking the mechanisms that produce human retinal cells, the whole process taking place in a plastic dish, suggesting that someday scientists "may be able to repair damage to the retina by growing rescue or repair cells from the patient's skin (Smith, 2009)." But so far differentiation has not been sufficient to apply the process clinically.

IPS cells have been differentiated into contracting cardiac cells by heart specialist Timothy Kamp, a University of Wisconsin professor of medicine in collaboration with stem cell pioneer Thomson. However, as the article stated, "much more research is needed before this type of stem cell can be used clinically (UW-Madison Heart Stem Cell Study Among Top Research Advances, 2010)."

In a paper published in the January 2006 issue of the Journal of Molecular and Cellular Cardiology, Kamp reported that embryonic stem cells, transplanted into mouse hearts damaged by experimentally induced heart attacks, shift gears and morph into functional forms of the major types of cells that compose the healthy heart. "It didn't completely repair the heart, but is was encouraging," Kamp said, noting that "clinical application remans a distant hope (Devitt, 2005)."

Neurons from mouse skin cells. Image by Thomas Vierbuchen, Stanford University School of Medicine.

Because of the inability of scientists to successfully differentiate for clinical use either embryonic stem cells or iPS cells, researchers have sought to bypass stem cells altogether, using the reprogramming methods developed in iPSC technology. Dr. Marius Wernig and colleagues at Stanford University School of Medicine inserted three genes into already differentiated skin cells taken from embryonic or young mice, converting them within 12 days into nerve cells, called nuerons, skipping the stem cell step altogether.

₁₇"This is much more straightforward than going through iPS cells, and it's likely to be a very viable alternative," Wernig said. However, he noted that much more research is needed before this type of procedure could be considered for clinical use (Mouse skin cells changed directly into nerve cells, 2010).

The third dimension
Growing tissue in a two dimensional environment such as a Petri dish has proven unsuccessful. So, what about a three dimensional environment?

Many biologists who are interested in stem-cell differentiation are starting to ask a big new question, says Douglas Kniss, a biomedical engineer at Ohio State University in Columbus: "How does the geometry of a tissue influence the biology of what cells become? (Nelson, 2007)" Scientists are turning to constructing scaffolds on which to build tissue, scaffolds that are made of artificial materials, such as polymers, and that are often sponge-like and porous.

Proposed method for growing differentiated cells on biomaterial scaffolds to construct whole organs or tissue suitable for transplant.

₁₈A proposed method for obtaining whole organs or tissue from embryonic stem cells was outlined by researchers Chou Chai, Duke-NUS Graduate Medical School, Singapore, and Kam W Leong, Department of Biomedical Engineering, Duke University, in the journal Molecular Therapy, published on-line January 30, 2007. They theorized that differentiated tissue could be seeded into sponge-like scaffolds, then transplanted :

ESCs [embryonic stem cells] may be derived from blastocysts obtained by either fertilization or somatic cell nuclear transfer under xeno-free conditions on biomaterial substrates. Derived stem cells can be expanded in culture on biomaterial-based bioreactors. Tissue scaffolds can be tailored according to the specific goals of the intended therapy. Expanded ESCs can be differentiated terminally into mature cell types before seeding into scaffolds to construct tissues or whole organs (Chai, 2007).

Terms such as "xeno-free," (meaning free of foreign material) "biomaterial substrates" and "bioreactors" are just scientific jargon used to describe artificial materials or structures, collectively called "scaffolds."

Close up of a culture of human osteoblasts growing on a three dimensional polystyrene scaffold.

Procedures have been carried out using such scaffolds. Researchers at the Technion-Israel Institute of Technology, Haifa, have created new heart muscle with its own blood supply using human embryonic stem cells. The researchers say the newly engineered muscle could replace cardiac tissue damaged in heart attacks. Their study was published online January 11, 2007, in the journal Circulation Research (Beating Heart Muscle With Built-In Blood Supply Created From Stem Cells, 2007).

This is the first time that three-dimensional human cardiac tissue complete with blood vessels has been constructed, according to Professor Shulamit Levenberg of the Technion Biomedical Engineering Department and Professor Lior Gepstein of the Faculty of Medicine.

₁₉The researchers engineered the heart muscle by seeding a sponge-like, three-dimensional plastic scaffold with heart muscle cells and blood vessel cells produced by human embryonic stem cells, along with cells called embryonic fibroblasts. Fibroblasts are connective tissue, functioning like the mortar between bricks.

Levenberg's research team used a similar technique in 2005 to grow skeletal muscle from scratch, and she says the lessons learned from that study helped in designing the heart muscle. For instance, the skeletal muscle study showed that it was important to grow all the different cell types together on the scaffold, and that the mortar-like fibroblasts were key to supporting the blood vessel walls as they developed. However, creating a beating heart suitable for transplantation can not be done as yet (Ritter, 2009).

Clinical trial put on hold
Generation of nerve tissue from stem cells has shown the most promise, with the first FDA-approved clinical trial involving human embryonic stem cell therapy being launched in January 2009 by California-based Geron Corporation. The goal of the trial is to restore function to patients with injured spinal cords (Geron Receives FDA Clearance to Begin World's First Human Clinical Trial of Embryonic Stem Cell-Based Therapy, 2009).

However, the FDA subsequently has withdrawn that approval, placing the trial on a clinical hold in August 2009, awaiting further data from animal experiments involving the new drug called GRNOPC1.

Evan Snyder, a neuroscientist who heads up the stem cell research center at the Burnham Institute for Medical Research in San Diego, commented that the research may not be ready for humans, saying that pre-human trials, which involved mice, should have been performed on larger animals.

"There's a lot of debate among spinal cord researchers that the pre-clinical data itself doesn't justify the clinical trial," Snyder, who is working on using neural stem cells himself, said (Ertelt 2009).

"In fact, the only thing Geron has done exceedingly well in its 13 years as a public company is surf the waves of stem-cell hype and use that momentum to raise lots of money," noted Adam Feurestein, senior columnist in his article "Geron's Stem-Cell Research Hype Soaks Investors" for TheStreet.com, which provides stock market analysis. He said following the initial FDA approval:

Geron reverted to this well-worn tactic again Thursday night, when it quickly sold 7.25 million shares at a price of $6.60, a 14% discount to the stock's Thursday closing price of $7.77. The spot-financing deal grossed Geron about $43 million (Feurestein 2009).

₂₀Geron recently announced it is collaborating with Corning Incorporated to produce a new synthetic growth matrix for the large-scale industrial "production of undifferentiated hESCs and their differentiated therapeutic cells." (Macdonald 2010) (Geron highlights product launch from collaboration with Corning 2010)

While so far unsuccessful at the clinical level, such experimental models and equipment give us clues as to what direction scientists must go and what obstacles must be overcome vis-à-vis embryonic stem cell research. One of the things learned is the importance of building on a scaffold and that the position of a cell, that is, its location, is important for it to thrive. A cell needs to know who its neighbors are. Placed merely in a test tube, such cells in effect get lost and can not grow correctly. Cells grow tissue like bricks form a building, and masons use scaffolds and don't start building in thin air.

But these are just glimmers of how to proceed.

"We create some external conditions, and then we have no control over the system. It does what it wants to do," says Gabor Forgacs, a biological physicist at the University of Missouri in Columbia, speaking about the differentiation of cells. "I'm still fascinated by the fact that they know what to do. We will never be able to reproduce, cell by cell, what nature does."

Their hope is that such extracellular things like scaffolds will encourage these cells to unfold on their own. However, so far their methods have not reached the state where embryonic stem cell therapy can be used to treat such things as heart or liver diseases, spinal injury or any other kind of ailment or defect. And controversy over the ethics of embryonic stem cell research haunts investigators.

3. Key problem differentiation

The goal of the regenerative scientists may be logically, structurally and chemically impossible. To obtain bodily parts, one may have to grow a human being first.

Key problem is differentiation
₂₁As noted, what researchers are trying to do is find some way to achieve differentiation into various bodily parts in a laboratory, circumventing pregnancy and on top of that, without the aid of the embryonic outer wall, the all-important magic room of the trophoblast.

Such a goal requires a great deal of hubris, akin to trying to grow a rose bud in a laboratory without growing the bush first. The goal of the regenerative scientists may be logically, structurally and chemically impossible. To obtain bodily parts, one may have to grow a human being first. Life may be something that must be achieved by developing it as a unit, instead of a part here or a part there.

To grow bodily organs or tissue, the key problem for all stem cell therapies is differentiation. And just what is that? Understanding the basic mechanics of this process will help one appreciate the difficulties facing researchers.

In the growth process from embryo to a fully developed person, various specialized parts of the body are formed as cells divide and differentiate. While cell division and differentiation are processes that are occurring at the same time, they refer to different aspects of development. As Dr. Bill Todt, Jones Science Center associate professor and chair of biology at Concordia College, Moorhead, Minnesota, explained during a recent interview:

Cell division is simply causing the cell to produce more cells like itself. Differentiation is the process of cells becoming specialized to do specific tasks or to have specific fates. Early on in the embryo, cell division is important, because in order to have cells becoming different from each other, you need lots of cells. As more and more cells are produced, then some of them can go ahead and start down their particular pathway and become different from their neighbors. That's the differentiation part.

Growth factors
To achieve clinically useful differentiation, researchers are trying to mimic what goes on naturally inside a cell. One method by which differentiation is achieved in cells is by chemicals called "growth factors." Aside from the method of genetic reprogramming, this is one of the most studied fields in differentiation.

The term growth factor refers to a naturally occurring substance capable of stimulating cellular growth and differentiation. Usually it is a protein or a steroid hormone. Growth factors are important for regulating a variety of cellular processes. They have the potential of directing the differentiation of stem cells into specific tissue types.

₂₂In one study, eight growth factors were applied to cultured human embryonic stem cells to observe their effects on cell differentiation by research teams led by Howard Hughes Medical Institute investigator Douglas Melton and Hebrew University geneticist Nissim Benvenisty, as reported in a research article published in the October 10, 2000 issue of Proceedings of the National Academy of Sciences.

Douglas A. Melton

What they found is that growth factors operate in a general way to begin with and did not directly work to achieve differentiation into specific cell types.

"When an egg cell divides, it doesn't immediately tell its daughter cells to become nerve, brain or pancreatic cells," Melton explained. "Rather, it first parses cells into the three general territories (germ layers)--ectoderm, mesoderm and endoderm. And, our studies showed that the growth factors encourage cells to develop into more of one germ layer and less of the other two."

Endodermal cells specialize into such organs as the liver and pancreas. Ectodermal cells become brain, skin and adrenal tissues. And mesodermal cells become muscle. But the research could not determine how the general category of cells became specialized. If you compared this process to building a house, the research produced a glimmer on how a building site (a germ layer) is established, but how to build a building (an organ) remained a mystery.

Ultimately, he said, controlling stem cell differentiation will likely involve a strategy that employs multiple growth factors in a certain order and at certain times.

"It may be a bit like educating a child, in which you don't designate children in kindergarten as doctors, lawyers or surgeons, but you give them some kind of general education." Melton noted. "And, as they progress and show an interest in a specific field, you give them a more specialized education."

"In the best of all possible worlds, one would like to find [that] growth factors could be added to a human embryonic stem cell to make it become a cardiomyocyte to replace defective heart muscle or a pancreatic beta cell for transplantation into diabetics," Melton said. "But these studies strongly suggest that finding such a factor will be exceedingly unlikely (Study Reveals How Growth Factors Affect Human Stem Cells, 2000)."

Trying to differentiate cells outside the environment of the embryonic walls, that is, in the laboratory, is sort of like trying to assemble a Mercedes Benz in your back yard, instead of on an assembly line, with a few tools from your garage. And no manual. And this would be a snap compared to what the stem cell research scientists are attempting to do.

₂₃One of the big hurdles in differentiation are processes called gene expression and induction. Understanding the basics of these biochemical processes will help explain why so far researchers using embryonic stem cells and iPSCs have reached a dead end.

Induction
As Dr. Todt pointed out, the growth from embryonic stem cells to a fully developed organism, such as a person, depends first on having a great number of cells and then on having those cells become specialized into various parts of the body. A cell's DNA stores the genetic instructions used in the development and functioning of all known living organisms. But, since all cells in each individual contain the exact same information as its neighbors (having the same DNA specific to that person), how do these cells become different form its neighbor? How do the cells containing the same information develop into different kinds of cells, say a heart cell or a nerve cell? How does "same" become "not same?"

It depends in part on what is called "gene expression." Like books in a library, the purpose of genes is to store information. Each gene is a book containing the information required to make a protein, the building blocks of a cell. In the same way that books may be taken off a shelf and read, genes are selectively read and transcribed or "expressed" to produce the protein molecules in every cell. What books are read and how they are read govern what characteristics a cell will possess (Twyman, 2003).

But just how does this system produce proteins that know exactly what kind of cell to be, say a heart cell, and where to go in the body? A heart does not grow in a foot nor an eye in a hand.

Who, what, where are you?
Stem cells as they divide and grow, begin to develop an uncanny sense. As the cells form the ball of a blastocyst and progress into various stages, the mass flattens and folds in on itself. As this growth transpires, cells begin to understand what they are, where they are and what their mission is by the process called "induction." As the experiments above indicate, a scaffold is often necessary to even begin to grow something like a heart. This is in part because cells grow and differentiate by sensing position.

Induction is the influence of one cell group over a neighboring cell group. Roughly speaking, cells during embryonic growth develop much like a blind person trying to set a table. As a blind person might touch a plate to see where the knife, fork and spoon goes, so cells grow and differentiate by sensing their position. For instance, the lens of an eye folds in on itself, giving rise to the optic cup and eventually the retina by the process of induction. It is thought that possibly chemicals on the surface of a cell possess the sensing information that controls this growth, producing signals that activate genes in still other cells (Mader, 2000). The necessary environment, that is, the necessary "scaffold," or terrain may be the growing body itself.

Mission impossible?
₂₄Recall that stem cells cannot grow into a human being without the presence of the embryo and its outer shell, the trophoblast. All they can do is multiply in a Petri dish, replicating themselves without end and without differentiation. What scientists are trying to do is mimic what an embryo does--without using an embryo, which includes both the stem cells and the trophoblast.

Can we grow a hand in a test tube?

They are trying to find the chemicals and their sequences of application that control the processes of differentiation and induction, attempting to build, for instance, a replica of a heart with cells on an artificial scaffold or attempting to grow a hand without growing the person. In sum, a goal of whole organ regenerative medicine is to grow a heart without growing a complete human body.

The problem facing these scientists is similar to the problem a cook would have in trying to make scrambled eggs into a egg. One can take an egg and put it in a bowl and scramble it, but can anyone take scrambled eggs and make an egg? You need a chicken to lay an egg to get an egg. In fact, a chicken can make an egg out of scrambled eggs. All it has to do is eat the scrambled eggs as feed.

One can take a dissected human hand and put it into a test tube, but will anyone ever be able to make a hand in a test tube? You need a human being to have a baby to make a human hand. In fact, an ordinary person can assemble a human hand out of scrambled eggs, along with all other bodily parts, simply by eating, conceiving and having a child.

But to do all this, you must start with a complete embryo, just like you need the full seed to grow a rose. Scoop out the insides and put the pulp in a Petri dish and nothing will happen no matter how much chemical fertilizer or water you give it--or how much money you spend.

So, just why is this? As mentioned above, the answer may lie in dimension, that is, you may need to go beyond the two dimensions of a Petri dish to a three dimensional construct.

₂₅As an illustration of the problems facing researchers, take a look at the photographs on the left. One is of the erection of a scaffold, the shell of a tall building. The other is of a scaffold to help sculpt a statute of a human being. In the picture of the scaffold of the building, note the construction workers dotting the structure. For our illustration, they will represent stem cells. Like the DNA in cells, these workers have all the plans, all the information, and all the ability to construct the building.

But without the scaffold, even with all this information and ability, they can construct nothing and will simply remain on the ground. The same goes for the workers on the scaffold working on the statue. Without the scaffold, no human form can be made. The scaffold functions like the trophoblast or the outer shell of the embryo. Without a scaffold, no rooms, no elevators, no electrical wiring, no floors, no facade and no windows can be made, nor can any hands, legs, head or arms.

What would be the result if a construction foreman decided to order the workers to build a room five stories up where the middle of the building should be, but without the scaffolding and without building the other floors first? It obviously could not be done. And how could the workers sculpting the statue make its shape without being in a position to do so by the aid of the scaffolding? They obviously could not do it.

Like scaffolding surrounding the developing embryo, the shell of the trophoblast enables the stem cells to assemble all the bodily parts. "a" is the embryo (stem cells), "e" is the trophoblast, "b" is the yolk sac that provides nutrients and "d" are projections called "villi" that tap into the maternal blood supply to feed the embryo.

Can you grow a heart without growing the body?
₂₆What researcher are trying to do may be like trying to erect a structure without a scaffold, or like trying to build an elevator without first erecting a building, or just building the top floor of a skyscraper, without the intervening floors, or, as initially mentioned, growing a rose bud without first growing a rose bush. It may be a mission that is logically and structurally impossible. It may be that to grow the heart or brain or skeleton of a body, you may have to grow the entire body. It may be that you cannot short-cut this process by simply growing a heart or a hand in a test tube. A Petri dish or a test tube or even an artificial scaffold may not provide the positional cues--such as the entire body does beginning with the embryo--to enable a cell to become a specialized heart cell.

From the shell of a blastocyst to a Petri dish, from an oasis to a glass desert.

Deprived of the environment that enables stem cells to develop into a fetus--with extracted stem cells finding themselves in a glass desert called a Petri dish or a plastic jungle called a tissue scaffold--it is not surprising that differentiation and growth into bodily parts does not occur. Glass--or even plastic, artificial scaffolds--may be too simplistic or incompatible to provide for differentiation and growth. What is needed is the trophoblast, that is, the entire embryo. The trophoblast in effect provides the scaffolding to begin with, and then as the body develops, the body itself becomes the scaffold.

It is no wonder then that to date no human embryonic stem cells or iPS cells have been successfully used to treat disease or injury. As the National Institute of Health puts it: "Although hESCs [human embryonic stem cells] are thought to offer potential cures and therapies for many devastating diseases, research using them is still in its early stages (FAQs, 2009)."

What to do?
₂₇So, what is a poor scientist to do? The solution is logically obvious--use the best building scaffold or manufacturing plant around--the complete embryo, that is, both the stem cells and the trophoblast, the insides and the outside. And in so doing, we are back to square one, for at some point an embryo, or a fetus, or a fully developed human being will be destroyed, regardless of whether we use SCNT or iPSCs or whatever.

4. All Roads Lead to Cloning

The language of the scientists and their supporters is clinical, meliorative and humane, but it gives off an unmistakable whiff of cannibalism.

The promise of cloning
Besides modifying stem cells in the laboratory, researchers have few other alternatives. If immunological rejection is to be avoided, the most logically evident alternative involves cloning.

Unable to accomplish differentiation in the laboratory from stem cells alone to date, some researchers out of necessity are turning to the less daunting process of SCNT, trying to copy the Dolly method for human beings, that is, attempting to use the entire embryo to achieve differentiation by implanting stem cells into an egg to artificially create an embryo.

While theoretically less challenging than trying to differentiate in a test tube, despite numerous research programs to achieve this end, no human being has to date been cloned beyond the blastocyst stage. But, they are getting close, and are progressing down two roads. (It is actually the same clonal road, but its name changes as you get further down it, changing from "therapeutic" to "reproductive.")

₂₈To obtain organs or tissue for transplantation or other cures, if cloning is used, a scientist has two clonal routes or alternatives, i.e., either "therapeutic cloning," or "reproductive cloning." Therapeutic cloning involves allowing the newly created embryo to grow in the laboratory for several days to achieve development leading to differentiation, then harvesting the resultant stem cells. Reproductive cloning involves the same process of SCNT, but instead of killing the embryo in a few days, the embryo is implanted in a mother and allowed to grow.

Cloning conventionally is achieved by transferring a somatic cell into an unfertilized egg through the process of somatic cell nuclear transfer. However, one could conceivably use an embryonic stem cell or an iPS cell for the nuclear transfer, instead of a skin cell. Regardless of what method is used, to utilize the clone for medical purposes, organs or tissue must be harvested from the clone. The quandry is when to harvest.

In reproductive cloning, such clones theoretically would grow up, and as either children or adults, have their organs harvested for medical applications, much like in "Never Let Me Go," Kazuo Ishiguro's recent and widely acclaimed novel about a young girl (a clone) coming of age on an organ farm--an English boarding school--where members were created and trained for no other purpose than to provide healthy organs for the sick and feeble.

At any level, whether therapeutic or reproductive, cloning leads eventually to a dilemma. It invites us to determine what class of beings deserve to be cured and what class of beings deserve to be bred and destroyed for their cure.

The whiff of cannibalism
In a review of "Never Let Me Go," in the November 27, 2005 New York Times, Gary Rosen, managing editor of Commentary magazine, said that while most decry reproductive cloning, therapeutic cloning is being pursued because it avoids immune rejection by drawing stem cells from embryonic clones of the patients themselves. Rosen noted:

Still, you don't have to be a raving Bible-thumper to entertain moral doubts about so-called therapeutic cloning ("therapeutic," that is, for potential patients; not such a great deal for the embryos). All you need is a bit of Kant from Ethics 101, especially the part about treating other people, presumably even proto-people, not as a means to your own ends but as ends in themselves. It is an injunction hard to square with the literature on SCNT, with its talk of "harvesting" and "programming" stem cells. The language of the scientists and their supporters is clinical, meliorative and humane, but it gives off an unmistakable whiff of cannibalism.

The time machine
One of the leading proponents of therapeutic cloning is Michael West, PhD, President and CEO of Advanced Cell Technology (ACT), a biotechnology company in Massachusetts. In an interview with Life Extension Magazine, West laid out his vision for therapeutic cloning in the cover story "Therapeutic cloning under fire." He called the cloned embryo the "time machine." He said:

The dream of cell biologists is to be able to take a body cell from a patient of any age back in time to an embryonic state. Embryonic stem cells have the unique ability to make virtually any type of cell that the patient would need. So their use in medicine could be very broad. One immediately thinks of making pancreatic islet cells for diabetes, heart muscle cells for heart disease, neurons for Parkinson's disease or spinal cord injury and so on. I believe we have found the "time machine." It is somatic cell nuclear transfer, otherwise known as cloning. The idea is quite simple. We would take a somatic cell from a patient and transfer it into an egg cell whose DNA had been removed. The egg cell would then act as the "time machine" by taking the patient's cell back to an embryonic state. Since the embryonic cell would be made through cloning, it would be immunologically identical to the patient's own cells and could then be transplanted into the patient without risk of rejection. The great hope is to be able to make young cells, tissues and organs for the treatment of aging and degenerative disease.(West, 2002)

₂₉Researchers are expending great effort along these lines. They are coming close to cloning a human being, and in fact, several have reached the first step. A pioneer in this effort is Advanced Cell Technology. According to the "Cloning Fact Sheet" by the Human Genome Project Information, U.S. Department of Energy, Office of Science, in November 2001, scientists from ACT announced that they had cloned the first human embryos for the purpose of advancing therapeutic research. The article stated that:

To do this, they collected eggs from women's ovaries and then removed the genetic material from these eggs with a needle less than 2/10,000th of an inch wide. A skin cell was inserted inside the enucleated egg to serve as a new nucleus. The egg began to divide after it was stimulated with a chemical called ionomycin. The results were limited in success. Although this process was carried out with eight eggs, only three began dividing, and only one was able to divide into six cells before stopping.

Patient-specific stem cells
As mentioned, one of the hopes of regenerative medicine is to develop a stem cell line of patient-specific stem cells, that is, colonies of stem cells that are copies of the patient's DNA. Such stem cell lines could be experimented on, using various drugs and gene therapies, to modify and correct diseased or injured tissue from patients. These modified tissues or organs could then conceivably be transplanted back into a patient to produce a cure of a specific disease or to replace a defective or injured organ. (Stem Cell Basics, 2009).

In fact, researchers from the Harvard Stem Cell Institute (HSCI) at Harvard and Children's Hospital Boston have launched an all out assault to produce human clones. Using somatic cell nuclear transfer, they are attempting to create disease-specific stem cell lines in an effort to develop medical treatments (Harvard stem cell researchers granted approval, 2006).

The project is a collaborative effort of 100 researchers, under the direction of Douglas Melton, co-director of HSCI and Assistant Professor Kevin Eggan of Harvard's Faculty of Arts and Sciences, Department of Molecular and Cellular Biology, and Harvard Medical School Associate Professor George Daley of Children's Hospital Boston.

(Melton, one of the most prominent persons in regenerative medicine, in addition to being the co-director of the Harvard Stem Cell Institute, is an investigator of the Howard Hughes Medical Institute, the Thomas Dudley Cabot Professor in the Natural Sciences of the Harvard University Faculty of Arts and Sciences, chairperson of the Harvard University Department of Stem Cell and Regenerative Biology, a faculty member of the Department of Molecular and Cellular Biology, a member of the National Academy of Science, a founding member of the International Society for Stem Cell Research, and is on the Science Advisory Board of the Genetics Policy Institute.)

Daley explained that the ultimate goal, once they understand how embryonic stem cells are programmed to differentiate into specific cell types, is to literally move a patient's disease into a Petri dish. "We plan to take skin cells from a patient with a genetic disease, like sickle cell anemia or any one of more than 40 bone marrow disorders, and reprogram that skin cell back to its embryonic state. We can then study the disease using these cells, correct their genetic defects and coax the repaired cells to become normal blood cells. Our ultimate goal is to return the repaired cells to the patients."

Theoretically, such cells, genetically identical to the patients receiving them, would be accepted by the patient's immune system and wouldn't require the use of immunosuppressive drugs. But in this research study, it would come at an ethical price--the harvesting of eggs and the destruction of an embryo.

But, Melton responds, "all human cells, even individual sperm and eggs, are 'living.' The relevant question is 'when does personhood begin?' That's a valid theological or philosophical question, but from the scientific perspective, this work holds enormous potential to save lives, cure diseases, and improve the health of millions of people. The reality of the suffering of those individuals far outweighs the potential of blastocysts that would never be implanted and allowed to come to term even if we did not do this research," he said.

The statement: "The reality of the suffering of those individuals far outweighs the potential of blastocysts that would never be implanted and allowed to come to term even if we did not do this research" is reminescent of the classic argument by researchers in regenerative medicine working with excess embryos from fertality clinics, saying that it is ethically permissible to experiment on these blastocysts because they would be discarded, anyway.

But that is not the case in this experiment. Unfertalized eggs are bing used: "Under the protocol approved by the Institutional Review Board (IRB) of Harvard's Faculty of Arts and Science, and the IRB of Boston IVF... ova will be collected for Melton and Eggan's work..." The blasatocysts are designed to be created from these eggs then discarded because of the research.

By the design of the experiment, the nucleus of an egg will be extracted and replaced by a patient's skin cells, creating a blastocyst in the laboratory. This blastocyst will then be shocked to start the cells to multiply. The experiment is designed to create blastocysts, then take out the stem cells to establish a stem cell line for the reasearch. The researchers never intend for the blastocyst to "come to term," but instead plan to harvest the stem cells implanted in the blastocyst to study how to repair the patient-specific cells and how to "coax" them into normal cells.

₃₀Let us deconstruct this Harvard reseacher's statement to see if it is true. Is it true that "blastocysts... would never be implanted and allowed to come to term"? Yes, because the design of the research is to harvest the stem cells before the blastocyst is implanted and allowed to come to term. Would the potential of the blastocyst be the same "even if we did not do this research," as they claim? Yes, for whether the research was done or not, if the artificially created blastocysts "would never be implanted and allowed to come to term," they had no potential either way. Thus, this is just an example of the deceptive language being used to cloud the mechanics of such stem cell research, namely, procedures designed to end embryonic human life.

Eggs needed
To do these studies, one needs a sufficient supply of women's eggs. Someday, we might read advertisements like this:

Egg Donors Needed. $10,000. Seek women who are attractive, under the age of 29 and have SAT scores above 1,300.

Someday? That someday is now.

Ads like this routinely appear in newspapers on college campuses and in Craigslist. The one above appeared in The Daily Californian, Berkeley, placed by a San Diego broker called A Perfect Match, trying to find an egg donor whose eggs would be fertilized by the husband of a women who could not ovulate, then implanted in her, his wife, achieving pregnancy. The child would be a genetic combination of the donor and the husband, but not the husband's wife, who would carry the child to term.

Such egg "donors" are being paid thousands for the retrieval and use of their eggs. "Donor," while it is the term being used, is a misnomer because compensation is involved. Although the National Organ Transplant Act of 1984 prohibits the transfer "of any human organ for valuable consideration for use in a human transplantation if the transfer affects interstate commerce," federal law neither bans nor directly regulates payments for sperm, eggs or embryos (Steinbrook, 2006) .

For sample advertisements see: Egg Donors Needed - $5500/donation! and Egg Donors Needed for Stay at Home Mom Income.

Stem-cell research could spur egg-donor demand, such as California's $3 billion embryonic stem-cell research program. While scientists mostly work with unused embryos stored at fertility clinics, for the newest research, they need unfertilized eggs. As explained in USA Today, scientists are involved with research that removes the egg's DNA, destroying the egg's original stem cells, then replacing it with DNA, that is, stem cells from another donor. The resultant embryo is allowed to grow, then after several days of growth in the laboratory, it, too, is destroyed when the stem cells are harvested for further research (Hopkins, 2006).

While federal funding of stem cell research is limited to certain existing stem cell lines, "there is no federal law banning human cloning altogether," according to the National Conference of State Legislatures. State laws on cloning vary widely, with some prohibiting research on cloned embryos, such as North Dakota, and other with no restrictions, such as Connecticut. Some states allow cloning, but prohibit the sale of embryos, such as California (Stem Cell Research, 2008).

Several California universities have indicated their interest in creating stem-cell lines with cloned human embryos, and for that, they'll need egg donors. They even have classes for prospective egg donors. The Institute of Medicine and the California agency that will distribute the $3 billion approved for stem-cell research in California, on November 19, 2009, sponsored a workshop on what is known about the risks of egg donation. In addition, California Gov. Arnold Schwarzenegger on September 28, 2006 signed into law a bill extending protections for women who donate their eggs for research, such as provisions for informed consent and outlining what are the potential risks of the procedure. (Palca and Block, 2009).

Humpty Dumpty science
We are developing sources of human eggs, but will cloning really work? Will it actually prevent immune rejection when tissue is transplanted from a clone? This so far can not be proved using cloned human tissue, because scientists can't clone tissue that is differentiated enough to transplant.

₃₁ "In fact, even to this day, a decade after the cloning of Dolly, scientists still have not cloned human embryos developed enough to generate patient-specific cells," Dr. Robert Lanza, chief scientific officer of ACT, said (Weintraub, 2008).

Putting the egg back together again to create a cloned human being is proving not so easy a task. In deed, it puts another light on the old nursery rhyme: "Humpty Dumpty sat on a wall. Humpty Dumpty had a great fall. All the king's horses and all the king 's men couldn't put Humpty together again."

Unable to go the next step at the human level, researchers at ACT turned to cows, finding that they could take a skin cell from a cow, put it into an embryo, let the embryo develop into a fetus, then kill the fetus, harvest its cells, and transplant those cells into the cow. The experiment showed that cloned tissue from an animal would not be rejected by the immune system. As the article stated:

In February 2002, scientists with the same biotech company reported that they had successfully transplanted kidney-like organs into cows. The team of researchers created a cloned cow embryo by removing the DNA from an egg cell and then injecting the DNA from the skin cell of the donor cow's ear. Since little is known about manipulating embryonic stem cells from cows, the scientists let the cloned embryos develop into fetuses. The scientists then harvested fetal tissue from the clones and transplanted it into the donor cow. In the three months of observation following the transplant, no sign of immune rejection was observed in the transplant recipient.

Profound implications: This experiment has profound implications. It demonstrated the utility of cloning and proved that fetal tissue cloned from a donor's skins cells could be used for transplant purposes without the side effects of immune rejection.

A big push by researchers is to get past the blastocyst state in the cloning of a human being. But, once we crack the blastocyst barrier in human cloning, literally all hell could break lose.

₃₂ACT's experiment with the cow demonstrated an intent of regenerative medicine: to harvest cloned human fetal tissue--that's right, tissue collected from the stage of development when bodily organs become apparent, the fetal stage. Scientists are trying to tell us something. It's just that they don't want to come right out and say it. They just whisper it: Pssst, we want to harvest body parts from human bodies raised for that purpose.

5. Hello, Frankenstein

"I saw the dull yellow eye of the creature open; it breathed hard, and a convulsive motion agitated its limbs." from Frankenstein or The Modern Prometheus

When you consider the value of life depending on a time-line, instead of from conception, it puts the person making the definition of human life in the driver's seat: life is life only after the time you don't need to take it.

An "amazing experience"
₃₃Although able to grow human clones for clinical use, researchers are continuing to make progress. In a report aired January 17, 2008. by NBC chief scientific correspondent Robert Bazell, Dr. Samuel Wood of Stemagen Corporation--a privately held embryonic stem cell research company in La Jolla, California--related an experience similar to the one Dr. Yamanaka had in looking down a microscope at an embryo (Bazell, 2008).

But instead of seeing what might be the embryo of one of his daughters, he saw his own embryo. As reported in the journal Stem Cell, Dr. Wood had cloned...himself.

Using material from his own skin, he inserted the nucleus into a human egg by means of nuclear transfer, creating stem cells inside the egg with his own DNA. He then placed it in a Petri dish and allowed it to divide, reaching the blastocyst or early embryonic stage. A research colleague also did the same thing.

"It was an amazing experience to look at that blastocyst and realize that it came from one of my cells," Dr. Wood said. "It's a bit like looking at yourself from a long time ago."

Indeed, that "long time ago" being immediately after his own conception.

As the MSNBC interviewer Bazell commented, "it is the first instance of cloning humans--only as embryos in a Petri dish, but still cloned human beings." Dr. Wood and his colleague destroyed the embryos and they did not develop into a stem cell line.

Actually, the first instance of cloning a human blastocyst was by ACT in 2001, as noted above. ACT's experiment, and the one by the Stemagen Corporation, demonstrated that a human clone can be created from skin cells, albeit at the very earliest stage of embryonic development. In the same manner, iPS cells could be used to grow clones. And that would require embryonic involvement.

₃₄Manufacturing humans: Bioethics Defense Fund President Nikolas T. Nikas commented that the news of human cloning being achieved at the blastocyst level by Stemagen Corporation, highlights the necessity of state and federal legislation banning the creation of cloned human embryos for any purpose.

"If true, the creation of human beings at the embryonic stage of life by cloning marks a new and decisive step toward turning human reproduction into a manufacturing process. The creation of human embryos for the purpose of exploitation as raw material for lab experiments is grossly immoral and a blatant violation of human dignity," said Nikas (Bordlee, 2007).

Petri dish just wont do
But growing a human being or a part of a human being in a Petri dish just wont do for the simple fact that so far, it just can't be done beyond a few cells at the blastocyst stage. What is happening is that science is trying to mimic in vitro, that is, in a controlled, nonliving environment, such as a laboratory, what is naturally done in vivo, that is, within a living organism. But since it can't be done in vitro, why not in vivo for organ harvesting applications?

Generally speaking, embryonic stem cells remain undifferentiated up to 14 days after fertilization. In nature, that is, in the body of a woman, fourteen days is the time when an embryo begins to implant in the womb. After that point, differentiation into various bodily parts beings to occur.

Coincidentally, fourteen days has often been cited as the window needed for "therapeutic cloning." In fact, legislation has been proposed in this regard. S. 876, a bill to prohibit human cloning and protect stem cell research, was sponsored in 2005 by Sens. Orrin Hatch, R-Utah, and Dianne Feinstein, D-Calif. The bill incorporated what it called the "Fourteen-day rule," namely that:

An unfertilized blastocyst shall not be maintained after more than 14 days from its first cell division, not counting any time during which it is stored at temperatures less than zero degrees centigrade (S. 876 2005).

In this context, "unfertilized blastocyst" refers to a blastocyst that has been subjected to somatic cell nuclear transfer, and while it may be "unfertilized," it grows following the administration of an electrical shock that starts embryonic development of the clone. The intent of the bill was to ban cloning for procreation but keep it legal for research.

"After 14 days, an unfertilized blastocyst begins differentiating into a specific type of cell such as a heart or brain cell and is no longer useful for the purposes of embryonic stem cell research," Feinstein told her colleagues (Saletan 2005).

However, just the opposite is true. Researchers want to go past, not stop, at 14 days. Being that researchers can't grow bodily parts in the laboratory, then the only other alternative would be to use the whole embryo, and if that is the case, then just the opposite would be the case regarding the research window of time needed for successfully cloning tissue and organs. Science, in fact life itself, would demand that you advance beyond the 14-day threshold. Here is why.

If the embryo starts to commit itself to certain fates or paths of development after about 14 days of cell division, then such stem cells cease to be pluripotent, that is, capable of growing into any type of organ, but instead become multipotent, that is, only able to grow into certain types of cells, such as a heart or liver. Thus, extracting stem cells from the blastocyst after 14 days does not give you pluripotent stem cells, and pluripotency is the hallmark of embryonic stem cells.

However, pluripotency is merely the defining characteristic of embryonic stem cells. That is what makes a stem cell a stem cell. But, pluripotency is not the goal of stem cell research. Researchers want to go beyond pluriipotency. The goal is to advance from pluripotent cells to multipotent cells to a specifically differentiated type of cell, such as a heart cell. As we have learned, if cloning is to be useful for transplantation purposes, tissue must be obtained that has differentiated. This means going beyond, not stopping, at 14 days of development. This means allowing the embryo to grow and differentiate, and this means progressing toward the fetal stage, that stage being where one can begin to see the distinct formation of bodily parts, that is, well beyond the ball stage of the blastocyst.

₃₅Apparently legislators were confusing the goals of embryonic stem cell research (to differentiate) with the definition of what is an embryonic stem cell (a cell that has not differentiated). Note that such bills have not passed. The reason for this most likely is that in private, scientists talked with supportive legislators and pointed out that the goals of regenerative medicine is to go beyond 14 days so as to differentiate tissue that can be transplanted, and that so far, they could not do this successfully in a test tube. Thus, limiting the development of the blastocyst would not be in their best interest.

Since researchers can't produce differentiate tissue suitable for transplantation in a Petri dish or in the laboratory from stem cells alone, what about using the whole embryo?

As we have seen, ACT demonstrated that fetal tissue cloned from a cow can be transplanted back into that cow and that the grafted tissue survived. This proves that cloned stem cells when differentiated will be accepted by the body and not rejected by the immune system.

But can stem cells be grown and cure disease? Again, an experiment by ACT answered that question by repairing the damaged hearts of mice with cloned tissue. Here is how they did it.

Researcher tied off a coronary artery leading to the heart of laboratory mice, inducing a heart attack and creating damaged heart tissue. By means of somatic cell nuclear transfer, cloned embryos were created and transferred to the oviducts of surrogate mothers. The cloned fetuses were allowed to develop in the mothers for 11 to 13 days, then recovered. To restore function to their damaged hearts, liver cells from the cloned embryos were injected into the dead heart muscle of live mice who had suffered the artificially induced heart attacks. By a process called "transdifferentiation" the liver cells in effect turned into heart cells.

As the research team reported, the process worked, concluding that: "stem cells derived from cloned embryos are sufficiently normal to repair damaged tissue in vivo."

To achieve this repair, the researchers had allowed the embryos to grow in the mice 11 to 13 days, equivalent to about five months in humans.

Notice we are in a different world now: in vivo instead of in vitro, that is, the experiments showed that differentiation can occur in a living animal, but not in a test tube.

However, they cautioned, "the approach used in this study cannot be applied clinically because the cells were obtained from fetuses and ethical principles require that preimplantation embryos not be allowed to grow beyond the blastocyst stage."

This is more mumbo-jumbo. Lanza's statement concerning the ethics of the procedure is strange when you consider that in another article titled "The Ethical Validity of Using Nuclear Transfer in Human Transplantation" he concluded that: "Strong ethical arguments can be made that this research is not only ethically permissible but imperative." He stated that:

The early embryo's lack of organs also makes it unreasonable to believe that it is in any way capable of having thoughts, feelings, or experiences. This leaves the embryo's potential for development into a human being as the sole consideration justifying according it significant moral weight. It is not clear, however, how much this potential should count in justifying its protection. Most entities with potential to develop are not valued or treated in the same way as their developed form. Eggs are not considered chickens and acorns are not considered oaks. The very high rate of early embryo loss also is relevant, with some estimates suggesting rates as high as 80% of all conceptions. In most cases, the great majority of embryos will not develop into a human being. This loss rate reduces the force of the potentiality argument.

He concludes that research is justified on early embryos because of their curative value and because they are less developed:

All these considerations support a developmental view that accords significantly lesser weight to the pregastrulation embryo and that justifies its use in research that could greatly benefit children and adults. Indeed, where research promises sufficient therapeutic benefit, this view may even morally require such research (Lanza 2000).

₃₆When you consider the value of life depending on a time-line, instead of from conception, it puts the person making the definition of human life in the driver's seat: life is life only after the time you don't need to take it.

His statement is even stranger, still, when you recall that he said: "In fact, even to this day, a decade after the cloning of Dolly, scientists still have not cloned human embryos developed enough to generate patient-specific cells (Weintraub, 2008)."

So far, it is not ethics that is stopping human cloning and its clinical application, but the inability of scientists to do so. His statement appears to have been made to divert the reader's attention from the fact that enormous sums of money are being spent on research that has a dead end not in ethics, but in the inabilities of science to create clinical uses of embryonic stem cells and human cloning.

Shell game
This is a shell game being played by scientists. What is a shell game? Come, let us look in on a game being played on the streets of Manhattan.

Standing in front of a cardboard box stood on its end, a man has placed three walnut shells on the top of it. He holds a pea up between his thumb and index finger, showing it to the crowd before him. He then places a pea under one of the shells and moves the shells around on the surface of the box, then stops, asking onlookers to bet on which shell contains the pea. You are only allowed to pick up two shells, he explains. One better takes up the challenge. He picks up one shell and finds no pea and then he picks up the other shell and finds no pea. All the onlookers laugh and the better, thinking he has lost, pays the bet and walks away.

The onlookers laugh again, because when the person running the game picks up the third shell, no pea is found under it, either. Instead it has been in his palm the whole time. And the onlookers, called "shills" were pals of the person running the game and were part of the fraud, being used to pressure the better into thinking he had lost.

Regenerative scientists are asking the public to bet on the shell game of embryonic stem cells, while they palm the pea, the pea being the embryo, human life, and the fact that to date, no scientist can differentiate stem cells for clinical use or clone a human being. The bet is that we can win big if we just compromise our ethics. And the shills are the media, its hype and the colleagues of the regenerative medical establishment. They are all in on the game, for the stakes are billions of dollars.

One instance of a media dupe to this shell game--or a willing collaborator, a shill--is William Saletan, the national correspondent for Slate magazine, a current affairs and culture magazine created in 1996 by former New Republic editor Michael Kinsley, initially under the ownership of Microsoft, as part of MSN, and purchased in 2004 by the Washington Post Company.

₃₇In an article surveying the progress of stem cell research titled "The organ factory: the case for harvesting older human embryos," Saletan observed that "differentiation lagged." But there was a way around this.

"Until scientists could grow the necessary tissues in the lab, they would have to enlist nature. Six to seven weeks of embryonic development seemed to do the trick," he noted, citing an Israeli study showing that:

when human and pig kidney precursors [the first cellular step toward differentiation] are obtained from 7- to 8- week human or 3.5- to 4-week pig gestation and transplanted into immundeficient mice, they survive, grow and undergo complete nephrogenesis, forming a functional organ able to produce urine. Embryonic renal cells of earlier origin fail to mature into the desired professional cell fate.

The authors of the study concluded: "Our data pinpoint a window of human and pig enmbryogenesis that may be optimal for transplantation into humans."

He ends by saying this about the ethics of harvesting human embryos:

But if all you want is tissue, who cares? You can tell yourself what we already tell ourselves about unwanted in vitro embryos: They're doomed anyway. Patents' lives are at stake. We can't let personal morality get in the way of science. We can't wait. But that's the funny thing: We are waiting. Every day that we don't grow embryos beyond two weeks for their tissue, we're waiting. I wonder why (Saletan, 2010).

"I wonder why," he asks? Well, for one reason, if a scientist is going to transplant tissue that will not be rejected, these embryos will have to go through the process of SCNT, whereby the nucleus is extracted and replaced by a patient's own skin cells. Yes, this is considered unethical by many because it destroys an embryo, but it is not ethics that is preventing going past the two-week period. It is the inability of science itself to produce a human clone, as noted above.

A study: economic gain vs. ethics
Possibly these skilled journalists and regenerative medical scientists have known all along that people are more likely to be motivated by ideas of economic benefit and scientific progress than by religious objections. So, as a fund-raising strategy, point out that it is religion that is stopping progress, not science, even if that is not true. Bank on people being more motivated by social and economic gain than by ethics.

A recent study has confirmed this, conducted by researcher Amy Becker, a University of Wisconsin-Madison graduate student, along with fellow graduate student Kajsa Dalrymple and faculty members Dominique Brossard, Dietram Scheufele and Al Gunther, in the UW-Madison's Department of Life Sciences. Published February 1, 2010, in the International Journal of Public Opinion Research, the following observations were made:

The new study is among the first to examine the stem cell issue in a specific political context and suggests that religious influence on the issue may not be as deep or pervasive as many believed. "What is really interesting is that religion and religious perspectives didn't motivate people to participate directly on the stem cell issue," notes Dalrymple. "People were more interested in the social and economic aspects of the stem cell issue."

However, what was most important in terms of motivating voters on the issue, says Becker, was attention to mass media coverage of the stem cell debate. A key finding of the new study suggests that attention to news media, in particular the written word in newspapers and on the Internet, was an important influence in spurring citizen participation.

The study confirms the importance of the media as "it was guiding voters and motivating them to get involved at the issue level," Becker explains, noting that portrayals of patients who might be aided by advances in stem cell research may have been particularly effective.

The message for candidates of all stripes, according to both Dalrymple and Becker, is that the news media continue to be a primary source of information and exert a strong influence on the electorate and that, at least in the case of embryonic stem cells, religious opposition can be effectively countered by using positive social and economic outcomes as a counterbalance.

The message for scientists, say the authors, is that their voices can be heard as more scientific issues enter the political realm. Says Dalrymple: "When science topics enter campaign discussions, there are opportunities for scientists to have their voices heard."

₃₈So, to have their voices heard receptively, and to achieve funding for this unethical science, it would make sense to deflect criticism of the progress of embryonic stem cell research by saying that it is ethics that is holding things up, not the inabilities of scientists themselves. And to achieve this favorable climate of opinion, what is needed is lots of media hype. And they are getting it. As Saletan rhetorically asked: I wonder why? Either the media is being deceived by being fed the wrong information, or they are in on the deception--they are the shills of the embryonic stem cell researchers.

And researchers could be reasoning thusly: What is wrong with unethical behavior toward an embryo if the outcome is improved lives for a multitude of people? And likewise, what is wrong with deceiving the public to obtain funding if the funding results in these improved lives?

Why stop here?
Yes, viable human clones have not been produced, but, as scientists make advance after advance fueled by billions of dollars from a deceived public, that day may come, and then the only roadblock will be ethics. And if and when this days arrives, why stop at the fourteen-day or two-week blastocyst stage, indeed? Leaving ethical concerns behind, maybe the scientifically viable solution would be to allow the embryonic stem cells to grow inside the embryonic shell, instead of extracting them and throwing the shell away. Why not proceed to the early embryonic stage in therapeutic cloning? (And the terms therapeutic cloning and reproductive cloning begin to blend, for really all cloning is reproductive.)

But, if we can get this far, why stop here? We will just use a little "developmental" reasoning. Why not opt for letting the embryo grow to a more advanced stage to get heart cells, say the fetal stage. If it can be done with a cow, why not a human? Why not implant the modified embryo in a human mother? When sufficiently developed, harvest the embryo or fetus and obtain the required organ, whether it be a heart or a hand. It could mean growing clones of oneself, and others, to eventually serve as organ donors.

The only problem is that at the embryonic level the heart as a whole organ is too small to pump sufficient blood if it were grafted into an adult patient's body. Time is needed to grow a large enough heart. So, why stop at the embryonic stage? Fetal cells can heal hearts, researchers have pointed out, so why not the whole heart? But, come to think of it, as a whole organ, the fetal heart is too small, also, so why stop at the fetal stage? We need a little more development.

Since we have come this far now, why stop here? Following implantation, just allow the clonal embryo to grow inside the womb, that is, let the embryo develop inside a mother, grow to term, and then be harvested at a size sufficient to produce a big enough heart--maybe at the child stage or young adult stage. The only problem is that "stage" is a person.

Given sufficient technological advances, what can logically be conceived by science, in the absence of morals and laws, could be done.

On the way to Frankenstein
Remember, we are being told by scientists and the media that going down this road is "imperative." We must sacrifice embryos to save lives, they say. And it is also being hinted that maybe a way around the ethical considerations is to make everything artificial--eggs, sperm, embryos and wombs. And it is also being argued that clones are expendable. But, where does this lead us? It could lead us to Frankenstein. In fact, he is lumbering toward us now.

And in this twilight world of the future, who would be the mothers, willing to go through nine months of gestation in her womb to produce children for the sake of organ and tissue donation? Alternatives are being explored by scientists.

For starters, maybe we don't need wombs.

₃₉Researchers are working to create a totally artificial womb. A team of scientists from Cornell University's Weill Medical College announced that they had succeeded, for the first time, in creating an artificial womb lining. The scientific team, led by Dr. Hung Chiung Liu of the Centre for Reproductive Medicine and Infertility, stimulated cells to grow into uterine lining, using a cocktail of drugs and hormones. According to an article in the Guardian by Jeremy Rifkin headed "The end of pregnancy--Within a generation there will be probably be mass use of artificial wombs to grow babies," the goal of the research is to help infertile couples by creating an entire womb which could be transplanted into a woman (Rifkin, 2002).

During an interview at the American Society for Reproductive Medicine Conference in 2001, Dr. Liu was asked: "Is it ... science fiction to say maybe in the far future you could have a real breathing embryo and have a child in the laboratory?"

"That's my final goal," Dr. Liu replied. "I call it an artificial uterus. I want to see whether I can develop an actual external device with this endometrium cell and then probably with a computer system simulate the feed in medium, feed out medium... and also have a chip controlling the hormone level." While conceding that such baby-incubating technology lies in the future, Dr. Liu said, "I believe this can be achieved, we could possibly have an artificial uterus so then you could grow a baby to term (Rosen, 2003)."

Illustration for the cover of Focus Magazine Italy on the design and development of a artificial womb

Indeed, maybe we don't even need mothers.

Yosinori Kuwabara and his colleagues, working in a small research laboratory at Juntendou University in Tokyo, are developing the first operational artificial "motherless" womb--a clear plastic tank the size of a bread basket, filled with amniotic fluid at body temperature. For the past several years, Kuwabara and his team have kept goat fetuses alive and growing for up to 10 days by connecting their umbilical cords to two machines that serve as a placenta, pumping in blood, oxygen and nutrients and disposing of waste products. While the plastic womb is still only a prototype, Kuwabara predicts that a fully functioning artificial womb capable of gestating a human fetus may be a reality in less than six years (Rifkin, 2002).

Research is proceeding to even create artificial eggs and sperm. Scientists at Stanford University claim they've found a way to make human embryonic stem cells turn into the types of cells that ultimately form sperm and eggs, according to a study reported in the journal Nature.

CBS News medical correspondent Dr. Jennifer Ashton explained how the scientists did it: "They took unused embryonic stem cells ... and then they put them in a lab, gave them some special cocktail of nutrients, proteins, some chemicals, and coaxed them into developing into early sperm and early eggs (Artificial Sperm and Eggs?, 2009)."

₄₀But, whether one uses an actual embryo or a mother, or an iPS stem cell, or an artificial embryo, mother, womb, egg, sperm or whatever, if the end result is a human life, you have to deal with the ethical questions regarding that human life.

And what about ownership?
What about ownership involving these discoveries? The person who discovered the method to create the first line of human embryonic stem cells is Dr. James Thomson, University of Wisconsin, listed as the "inventor of human embryonic stem cells."

In 1998, the U.S. Patent and Trademark Office (PTO) issued a broad patent claiming primate (including human) embryonic stem cells, entitled "Primate Embryonic Stem Cells" (Patent 5,843,780). On 13 March 2001, a second patent (6,200,806) was issued with the same title but focused on human embryonic stem cells (Biological patent, 2009).

The owner of the embryonic stem cell patents is the Madison-based Wisconsin Alumni Research Foundation (WARF), a technology-licensing organization associated with the University of Wisconsin, with $1.6 billion in assets.

The 1998 patent reads as follows:

We claim: 1. A purified preparation of primate embryonic stem cells which (i) is capable of proliferation in an in vitro culture for over one year, (ii) maintains a karyotype in which all the chromosomes characteristic of the primate species are present and not noticeably altered through prolonged culture, (iii) maintains the potential to differentiate into derivatives of endoderm, mesoderm and ectoderm tissues throughout the culture, and (iv) will not differentiate when cultured on a fibroblast feeder layer (Loring, 2007).

A patent on life: U.S. patent for "Embryonic stem cells and methods of obtaining them"

By claiming ownership of a stem cell's ability to replicate itself in vitro, that is in a Petri dish in the laboratory, WARF is claiming ownership of the very process that governs the creation of life.

₄₁These patents are being challenged by group of three individuals: Jeanne Loring, director of the Center for Regenerative Medicine at The Scripps Research Institute, Dan Ravicher, an attorney who has founded the Public Patent Foundation in New York to challenge patents that threatened the public interest, and John Simpson of the Foundation for Taxpayer and Consumer Rights in Santa Monica, California. On 17 July, 2006 they requested that three "Primate Embryonic Stem Cell" patents be re-examined by the US Patent and Trademark Office (Loring, 2007).

Loring said the patents should never have been granted because earlier work by other researchers made the science "obvious and therefore unpatentable."

However Simpson's non-technical reason was more to the point. "It's absolutely absurd that one person or organization could own the rights to life itself," he said. (Stem Cell Patents Come Under Fire, 2006).

Why is it absurd? Because looking at human life as capable of being owned, even at the stem cell level, is opening the doors to slavery. And slavery presumes the right to that person's life. Further, it is scientific arrogance to claim that the discovery of a life process created by God is a human invention.

However, to date, these patents have been upheld by the patent office, meaning that the University of Wisconsin Alumni Research Foundation will continue to control primary intellectual property rights to embryonic stem cell research in the United States (Foley, 2008)

As morality collapses within the scientific community, so this community begins to collapse itself.

Stem cell fraud
Scientists have struggled for years to produce a stem cell line of cloned human beings. Several years prior to Dr. Wood's successful cloning of himself, a South Korean biomedical scientist Woo-Suk Hwang claimed to have succeeded in creating human embryonic stem cells by cloning. Time Magazine featured him in its choice of "People Who Mattered 2004," in its Person of the Year issue, writing that:

A veterinarian by training, Hwang began to research cloning for a practical purpose: he wanted to create a better cow. But his work didn't stop in the barnyard. Hwang and his team at Seoul National University became the first to clone human embryos capable of yielding viable stem cells that might one day cure countless diseases. While such research raises troubling ethical questions, Hwang has already proved that human cloning is no longer science fiction, but a fact of life (People who mattered, 2004).

Disgraced stem cell scientist Hwang Woo-suk guilty of fraud

₄₂A panel of Seoul National University experts later found that Hwang had faked the results of the stem cells lines he claimed to have created. He was indicted on embezzlement and bioethics law violations involving millions of dollars in privately donated research funds he had accepted for the feat. On Oct. 27, 2009 Rueters carried the headline: "South Korea stem cell scientist guilty of fraud." After a trial that stretched over three years, the court sentenced Hwang--once a scientist with rock-star like status for bringing South Korea to the forefront of stem cell studies--to two years in jail, suspended for three years (Kim and Herskovits, 2009).

Why is there fraud in the stem cell field? Possibly because where absolute standards are violated, such as the absolute right of all people created on earth to live, then the ends justify the means and truth does not count. The reasoning could conceivable be that if one can advance stem cell research which will supposedly benefit mankind, why not lie, if that is what it takes? And where truth does not count, you do not have science.

Not spare parts
The truth is that stem cell research at the embryonic level takes lives. President Bush, in signing his first veto rejecting legislation that would ease limits on federal funding for embryonic stem-cell research, stated why such research is unethical. As he signed the bill, he was surrounded by 18 families who had "adopted" frozen embryos that were not used by other couples, and then used those leftover embryos to have children.

Families who had adopted "leftover" embryos surround President Bush as he signs veto.

"Each of these children was still adopted while still an embryo and has been blessed with a chance to grow, to grow up in a loving family," he said. "These boys and girls are not spare parts (Roberts, 2006)."

But, science is trying to make them so. When you transgress moral laws, such as "thou shalt not kill," you enter a world were eventually everything goes.

Legislators got a glimpse of the new world we are entering when researchers testified before a committee formed by President Bush called the President's Council on Bioethics. In April 2002, they heard from John Gearhart, one of the field's top researchers,who published a study of human cells "derived and cultured from 5-, 6-, 7- and 11-week postfertilization primordial germ cells." These cells are "precursor" cells headed toward becoming fully differentiated cells.

₄₃The derived cells, unlike hES cell lines from embryos before 14 days, caused no tumors when they were injected into mice. Gearhart's team found that the derived cells "may be useful … as a resource for cellular transplantation therapies." When Gearhart testified, he was asked, "Would it in fact be the greatest advantage if a patient's own cell line could be derived from primordial germ cells?" He was flustered in his reply:

Oh, boy, this committee would--well, wow. Now, think what this means. It means that you would be generating an embryo, and having it implanted. Now, what you don't know is that our fetal tissue comes from 5-to-9 weeks post-fertilization. These are therapeutic abortions. And which means now that you are way beyond--I mean, the point of where a blastocyst is, and obviously way beyond I think anyone subscribing to that approach (Saletan 2005).

In other words, the research demonstrated the utility of using cells harvested from an embryo implanted in a mother--a process that would involve allowing the embryo to grow, then aborting the unborn child nine weeks later to retrieve the fetal tissue for transplant purposes.

Welcome to the organ factory
Now let us look in more detail at Dr. Liu's experiments with artificial wombs. Using uterine cells grown on a biodegradable scaffold bathed in a broth of hormones and nutrients, she placed fertilized human embryos created during IVF treatment onto the wall of the artificial womb. She observed that they nestled into it and began to attach themselves to the endometrial cells making up the lining--just as in the early stages of pregnancy. Liu stopped the experiments after a week.

Liu says she has now grown mouse fetuses in her artificial womb for 17 of their 21-day terms. This is equivalent to about 31 weeks in humans, a point at which if born prematurely, humans can be nurtured to normal development. Just as with the human embryos, the tiny bundles of mouse cells nestled into the artificial lining of the womb and began to attach themselves. Liu watched as blood vessels formed, then miniature placentas and, eventually, the amniotic sac--an embryo's personal protective bubble. Peering inside, however, she found the fetuses were severely deformed. She continued experimenting, but with no success (Adam 2005).

But, her experiments show a direction research is headed. We are perfecting the crafting of artificial eggs. We can clone a patient's cells from his own skin. We are experimenting with growing that clone in an artificial womb so as to create tissue that will not be rejected by the immune system and that will be ideal for transplanting organs and tissue back into that patient. No mothers, no fathers are needed. We are headed toward human organ factories or farms.

The prototype of these farms are already in existence now vis-à-vis embryonic stem cell lines, where laboratories are filled with human embryonic stem cells multiplying day by day. Geron Corporation's newly developed matrix containers--designed for the large-scale replication of hESCs--are a further step toward the industrialization and instrumentalization of human beings and the manufacturing of body parts.

Aldous Huxley in his novel Brave New World foreshadowed this world, writing, "One by one the eggs were transferred from their test-tubes to the larger containers; deftly the peritoneal lining was slit, the morula dropped into place, the saline solution poured . . . and already the bottle had passed on through an opening in the wall, slowly on into the Social Predestination Room.''

₄₄And so did British author Mary Shelley, in her novel Frankenstein or The Modern Prometheus. The book recounts a story about a scientist, Victor Frankenstein, who learns how to create life, assembling a monster in his laboratory out of body parts from the "dissecting room and the slaughter-house." The creature came to be known as "Frankenstein." She wrote how one night the scientist stood over his work:

It was on a dreary night of November that I beheld the accomplishment of my toils. With an anxiety that almost amounted to agony, I collected the instruments of life around me, that I might infuse a spark of being into the lifeless thing that lay at my feet. It was already one in the morning; the rain pattered dismally against the panes, and my candle was nearly burnt out, when, by the glimmer of the half-extinguished light, I saw the dull yellow eye of the creature open; it breathed hard, and a convulsive motion agitated its limbs.

In this Brave New World we are approaching today, Dr. Frankenstein would rule. And it is not the potential clones who would be Frankensteins, but their creators. Without proper ethical and legislative restraints, we, as members of this nation, run the risk of participating in a moral monstrosity. We run the risk of creating two classes: those who deserve to be cured and those who deserve to be sacrificed.

The research leading to this nightmare is being funded by deception. The regenerative medical establishment is on purpose misleading the public with the support of a hysterical media that rants and raves that the only thing that is holding up miraculous cures is ethics, when in fact, after years of effort, clinically useful tissue or organs have not been differentiated from embryonic stem cells nor from iPS cells in the laboratory. Nor, has human cloning as yet been achieved. In the process, nascent human lives are being preyed upon in the form of embryos and embryonic stem cell lines and billions of dollars are being funneled away from the more productive and ethical research involving adult stem cells.

So, what should be done? A moratorium should be placed on embryonic stem cell research and human cloning. It is a Humpty Dumpty science sitting on a wall composed of academic research institutions, research corporations, politicians and the media. The wall they have formed is a fabrication.

The rationale and structure for such a moratorium will be explored more fully in Part III. In relationship to stem cell research, what it means to be human and the importance of the individual will be explored in Part II.

Citations:

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# # #

Hello, Dolly… Hello, Humpty Dumpty... Hello, Frankenstein

Table of Contents 1. Baby, its you and you and you 2. Hello, stem cells 3. Key problem differentiation 4. All roads lead to cloning 5. Hello, Frankenstein

1. Baby, its you and you and you

2. Hello, stem cells

3. Key problem differentiation

4. All Roads Lead to Cloning

5. Hello, Frankenstein

Illustration for the cover of Focus Magazine Italy on the design and development of a artificial womb

A patent on life: U.S. patent for "Embryonic stem cells and methods of obtaining them"

Disgraced stem cell scientist Hwang Woo-suk guilty of fraud

Hello, Dolly…
Hello, Humpty Dumpty...
Hello, Frankenstein

Table of Contents
1. Baby, its you and you and you
2. Hello, stem cells
3. Key problem differentiation
4. All roads lead to cloning
5. Hello, Frankenstein