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The Proposal ***

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The Max Weber Institute for the Study of the Fifth Day of Creation, (The Institute), proposes to furnish to The Benefactor quarterly Reports as the Research progresses in the Human Trials of various Experimental Treatments to  be conducted outside the United States on non U. S. Patients suffering from those Diseases or Conditions as specified by The Benefactor.     

 

The Benefactor:

The profile of The Benefactor is any persons of means whose declining health makes, the six or twelve year delay in obtaining F. D. A. or N. I. H. approval to proceed with clinically supervised human trials of promising medical Experimental Treatments, useless. 

 

The Patients:

For every Benefactor there will be dozens of Patients who suffer the same Disease or Condition as The Benefactor but for whom no medical treatment is available due to The Patient’s situation.  For these Patients The Benefactor’s research is their only possibility for medical care.

 

Experimental Treatment:

There are a great many techniques now awaiting the completion of Animal Model studies.  Animal Model studies are not necessarily applicable to humans.  After this academic research is completed application can then be made for governmental approval for Human Trials.  Regardless of the outcome of the Animal Studies human studies must be conducted.  There must always be a first human subject.  After perhaps a decade of delay, the Phase one of governmentally approved Human Trials can then commence. However, Phase one trials tests not if the Experimental Treatments are beneficial but only if they are toxic, a process which can itself take years.  It is not until Phase two trials  are completed, again a period of years, that actual experimental results can be evaluated.

 

The Proposal will eliminate these decade long delays.  At one time, when toxic chemicals were being employed in Experimental Treatments it made sense  to engage in this drawn out process.  However with the advent of regenerative medicine the new medical techniques involve using The Patient’s own genetics.  There is no risk of toxicity as we are introducing The Patient’s own genetic material back into his body.  For the same reason Animal Models though still important are less applicable.  Even though humans share many genes with other species they express themselves differently in humans than they do in the other species.

 

For example, one promising area of research is stem cells.  The Institute proposes to skip further Animal Studies and reintroduce The Patient's own stem cells back into The Patient’s body.  Arguably this does not even qualify as an experiment as the cells that are being transfused back into The Patient are The Patient’s own cells.  Animal Studies have shown that DNA becomes impaired (ages) over time, however, when the subject’s DNA is placed in, (cloned into), an embryonic cell the DNA is repaired and rejuvenated.  This process of cloning the DNA into embryonic cells is technically referred to as: ‘creating a line of cells.’   

 

Therefore, one phase of our proposed research involves creating a line of stem cells for each Patient and then reintroducing these corrected cell ‘lines’ back into The Patient’s body.  Again there is no question of ‘toxicity’ as these are The Patient’s own cells.  Therefore there is no need for so called Phase one trials. 

 

There will always have to be a first Human Trial.  And remember The Patients have no hope for any medical treatment if The Benefactor does not sponsor this research.  The Patients are in the position of either getting the most advanced treatment or no treatment at all.   Therefore, as to The Patients, The Institute sees no moral issue.  We did not create the social order that deprived these individuals of the opportunity for medical treatment.  If not for The Institute these individuals would have no hope at all.

 

With respect to the embryonic cells whose nucleic material was removed and replaced with The Patient’s own corrected DNA The Institute sees no moral or ethical issue and questions the good faith of those who now protest and attempt to delay human progress with needless delay. 

 

First, if you are so concerned with “human life” may we ask, why are our Patients not given any medical care at all save for the medical treatment we provide?   Your claims of ethical concern are fraudulent.  Why does the United States import half of its medical doctors every year?  Why isn’t the U. S. sending doctors out into the rest of the world?  Why are you importing doctors from a world in such need?  Why are you not sending doctors out to this world with its crying need for medical care?

 

One word answer:  money.  Hypocrites.  The people who can afford to go through your “medical training” would not take up the medical practice that you farm out to foreign trained doctors.  The good medical positions are filled by American trained doctors and lower cost doctors fill in the rest.  Thus is the world  drained of some of its best doctors.

       

And then when The Institute tries to advance the cause of medicine we are forced to listen to your hypocritical whining.  Concern for the blasticist?  Liars.

Experimental Treatment, example number two:

 

Thus far in our evaluation of the ethical issues The Institute has denied the legitimacy of concerns of opponents of the new regenerative medicine, but let us now examine a second example which presents a more difficult case.  Recent attempts to use stem cells to treat humans have shown that embryonic stem cells sometimes form tumors rather than integrating into The Patient’s body.  Therefor so called ‘adult stem cells’ and even tissue specific stem cells have been suggested as an alternative.  If the adult stem cells can be corrected and repaired the situation is much the same as was discussed in the first example.

 

However, if tissue specific stem cells are to be derived from the embryonic line a moral issue presents itself.  If the embryonic cell is allowed to continue to divide and develop nascent organs, i.e. if the cloned embryo is allowed to gestate and develop human like traits, e.g. organs, should there be limits imposed on the research because of ethical reasons alone?

 

Our answer at The Institute, after years of careful research is:  no.

 

First consider that the developing embryo first starts to differentiate tissue within days, weeks, of development.  Once the cells have started to locate into recognizable areas of the organism, i.e. heart, lungs, etc., these cell lines can be cultivated into lines just as in the earlier example.  Now instead of a line of stem cells, one has a line of  ‘lung stem cells,’ ‘heart stem cells,’ and so forth. 

 

Let us pause for a moment to reflect that these moral issues are a large part of the reason why research is being delayed.  Therefore The Benefactor should note that progress, in the United States, will of a consequence of this debate be delayed:   and therefore, The Proposal!  If The Benefactor is ever to benefit from this emerging medical technology it will be from experiments performed outside the United States. 

 

To return to our review of the ethical issue:  note that the now differentiated zygote is in essentially the same moral situation as it was when first we intervened in the earlier example, before the cells began to differentiate themselves, and both share the same legal status.  Though legal status is not synonymous with moral status it is worth reflecting that the developing cells of the embryo, zygote, and fetus can be legally terminated without cause or reason or explanation at any time up to the end of the first trimester.  In this example the moral issue is what duty is owed after not three months but perhaps only three weeks? 

 

Again, our answer here at The Institute is: none.

 

Consider that this developing zygote is a genetically engineered product, growth, of The Patient whose nuclear genetic material has been used to engineer it.  What is the age of the zygote?  Three weeks or three weeks plus the age of The Patient from whose body it was extracted, engineered, corrected, inserted, and cultivated?  Indeed a more thoughtful question is what is the real age of any of us?  We each of us have genetic material given to us from our very first mother who begot us all.  Our genetic material in our living cells is billions of years old.  Four billion years old at least in part. 

 

Earlier we mentioned that we share many genes with other species.  Perhaps 99% of “our” genes belong to our fellow creatures, our brothers and sisters, and date back hundreds of millions of years, billions of years in part, back over the long eons when we were literally one.  We ‘descended,’ as we say, not from a “common ancestor,” but rather “we” were that common ancestor:   the “we” in question being that bit of nuclear material, that DNA, that our critics want to now call “us.”  

 

The layman will think it an easy task to differentiate where we begin and the rest of the universe leaves off, but in fact, on closer examination, the problem is not so clear cut as will at first be supposed by those who have never had to attempt the explanation.  Go ahead, argue with your straw men all you like, however, if one is forced to defend the distinctions one will quickly be made to agree there is at least a considerable over lap.

 

Given that The Patient’s cell lines that are growing in our laboratory are at least as old as The Patient, and by our reckoning here at The Institute, possibly billions of years old, the hysteria over a two, or three,  week old zygote seems scarcely creditable.  Whose body is it?  What can freedom mean if we are not free to culture our own cells to save our life?

 

For example, if The Benefactor has a respiratory Disease or Condition, we propose to culture a line of lung stem cells from The Patient, (who also suffers from the same Disease or Condition), and inject these cells into The Patient’s lungs.  These tissue specific cells will avoid the problems discovered in other Human Trials performed by other researchers.  We at The Institute see no moral or ethical issue at all.  A portion of The Patient’s body has been temporarily grown in culture in the laboratory and then transplanted back into The Patient’s body.  In this manner billions of cells can be used to rebuild The Patient’s body damaged by surgery, or radiation, or chemotherapy, or just age. 

 

There would have been no zygote except for The Patient and our intervention.  The zygote had no independent life.  To assure this the neuron stem cells can be removed as they develop.  These too can be infused into The Patient.  For example, nerve damage that results in loss of hearing can be repaired by injecting new neurons into The Patient. 

 

And again, let us pause and reflect that it is just this debate which necessitates off shore experimentation such as we propose.  If The Benefactor waits for a resolution of this moral debate then The Benefactor will wait forever --- ups,  not forever, until he is dead.  (Don’t be patient, act now!)

 

What is the weight that should be given to the zygote in the scales of justice when we add the weight of The Benefactor and The Patients and the rest of mankind?   

.

***Legal Notice:

This proposal is for purposes of illustration only.  The Proposal will be negotiated, completed, and executed in a Third Country by The Benefactor and The Institute, in accordance with the Laws of that Third Country and all applicable International Law and Regulation.  Where Human Trials are not permitted by the Law, Animal Studies will be substituted.  All Patients will be drawn from countries other than the United States and the Third Country where The Proposal is executed.  All Human Trials will be conducted in countries or international waters other than the United States or the Third Country where The Proposal is executed.  The Institute warrants that all Patients will be treated with due care in accordance with the Best Current Medical Practice, and in no event shall Experimental Treatments be conducted without the Informed Written Consent of The Patient.  The Institute warrants that all Patients will manifest the Disease or Condition as specified by The Benefactor and that the Experimental Treatments will be performed in accordance with The Protocol as specified by The Benefactor in The Proposal.  Additional Reports will be provided by Specialists as specified by The Benefactor in The Proposal. 

 

 

 

 

 

17 November 2004

Technology and Innovation are at the heart of the Department for Trade and Industry's (DTI) five-year plan outlined by Prime Minister Blair:

 

 

Our ambition is for the UK to become the science capital of the world, to become a world leader in exploiting knowledge, to become the most open and supportive environment in the World. A place where scientists everywhere in world want to come and work. We are well on the way. But I believe we can do better. Stem cell research is just one example of a new area of science which has tremendous potential to improve quality of life and where the UK can lead the world.

 

A hundred years ago life expectancy was 45 years. Today it is 76 for men and 81 for women. But living longer also means that diseases that were much rarer then are much more common today. Until recently there has been little prospect of finding a cure for them. Stem Cell research changes that and has the potential to revolutionise medical advance.

 

I know it is an area which is controversial but properly regulated stem cell research could transform the life chances of people suffering from Parkinson's, Alzheimer's, strokes and spinal cord injuries for example. We will not stop this research. The potential benefits are huge. I do not think it is right to deny people suffering from these illnesses the hope of a cure. But we are not allowing it simply to proceed unregulated.

 

As a result of many years of public and parliamentary debate the UK has one of the most comprehensive schemes of stem cell regulation in the world. We have the UK Stem Cell Bank - a world first where the first two human embryonic stem cell lines were deposited earlier this year. We should have the confidence to recognise that science can be a force for good and to grasp the opportunities that it presents to us.

 

The Government is sending a strong signal today - which we will reinforce around the world in the coming months - that the UK is the place to carry out scientific research like this. The UK can be the world leader in stem cell research, biotechnology etc. The DTI Plan will help ensure that the UK continues to create a climate where this sort of research can flourish.

 

If we are to achieve this vision we must redouble our efforts to tackle Animal Rights Extremism. Britain has the most tightly controlled regime governing animal experiments in the world. To do any experiments involving animals scientists have to go through a rigorous process to gain a licence. And licences are only granted if there is no alternative.

Because we have such a tight regulatory regime and because the benefits from such research has alleviated suffering for millions of people - from HIV to Asthma animal experiments have been vital in developing new drugs and medicines - we will not tolerate the sort of violent and intimidatory activity we are seeing from Animal Rights Extremist.

That is why we produced a detailed strategy for dealing with extremists in July. We are implementing this strategy with the police and others.

 

And we are prepared to go further. That is why we are consulting industry on how to create a new offence to address the economic damage extremist can cause companies and their suppliers.

 

But investing in science and fostering excellence is only part of the task. For far too long UK scientists and engineers have come up with ideas which in the end have had to be developed abroad. We aim to change this and make "Discovered in Britain" into "Made in Britain" too. That means matching excellence in invention with success in taking ideas to the market place. And that requires strong networks linking our universities and businesses. The DTI's 400 million Technology Strategy will strengthen these networks and help business turn new ideas into commercial reality.

 

 

 

News extra  03-19-2005

Activating stem cells may treat Alzheimer's

New York Janice Hopkins Tanne

Stem cells offer promise in treating neurodegenerative diseases but not in the expected way, according to researchers at the annual symposium on dementia and Alzheimer’s disease, sponsored by the Albert Einstein College of Medicine and Montefiore Medical Center in New York.

Longevity genes might protect against Alzheimer’s disease and combining drugs and non-pharmacological interventions might slow the disease. Researchers recommended a quick office test to identify patients with early dementia.

Cases of dementia cases in the United States are expected to double in the next 40 years, said Gary Kennedy, professor of psychiatry and behavioral sciences at Einstein and director of geriatric psychiatry at Montefiore. Currently, Alzheimer’s disease alone affects 8% to 15% of American citizens aged at least 65, he said. He added that modest interventions would help patients and care givers by postponing decline.

Stem cells are present throughout the brain and, if doctors knew the signals, could be activated to repair injury due to stroke, trauma, multiple sclerosis, or neurodegenerative diseases, such as Alzheimer’s disease, said Mark Mehler, chairman of the neurology department at Einstein. "Pharmacology [to treat dementia and Alzheimer’s] is not selective. We need to understand the basic biology," he told the BMJ. Stem cells in the brain need to be activated within specific brain regions, where they have molecular signals to integrate them with other brain cells. Just transplanting stem cells into the brain and hoping they will work will not be effective, he said.

Although the ability to activate stem cells in the brain was "years off," Dr Mehler told the BMJ that the drugs used in cancer chemotherapy may affect proteins altered in neurodegeneratives diseases. The interleukins, colony stimulating factors, and erythropoietin cross the blood-brain barrier, which becomes more porous in neurodegenerative disease, he said.

Also speaking at the conference, Nir Barzilai, director of Einstein’s institute of ageing research, reported that three genes may explain why only one in 10 000 people live to be 100. His study included more than 1200 people, 300 Ashkenazi Jews (Jews of Eastern European descent) aged 95 to 108, their spouses, and their children, many of whom have already lived beyond the US average lifespan.

The CETP gene, which regulates lipoproteins, is found in about 8% of 65 year olds but in 25% of those who live to 105. Lipoproteins move cholesterol and triglycerides through the bloodstream and may increase high density lipoprotein, the "good cholesterol." People with the CETP gene have unusually large lipoprotein particles, but no one knows how this might be protective. People with this gene also have good cognitive function in old age. Two other genes, apoC-III and APM1, also seem connected to longer life, he said.

Steven Hahn, professor of clinical medicine at Einstein and director of the primary care internal residency programme described a test for dementia that can be done in a primary care setting. About 75% of dementia is not recognised by outpatient providers, but the memory impairment screen is a convenient detection test.

The patient is given a written list of four words and asked to read them aloud and remember them (the words history, factory, policeman, and toothbrush are often used). The person giving the test also tells the patient a cue for each category (for history, "something you might have studied in school").

The test giver involves the patient in unrelated discussion for two minutes and then asks the patient to recall the words. Two points are scored for each word freely recalled and one point for each word recalled on cue. Scores of four or lower predict dementia with a sensitivity of 0.87 and a specificity of 0.96

Copies of the test are available from harb@aecom.yu.edu.

 
 
 

04-30-05

 

Genetic Mingling Mixes Human, Animal Cells

By PAUL ELIAS, AP Biotechnology Writer

 

http://www.latimes.com/news/science/wire/sns-ap-human-animal-mixing,1,40673.story?coll=sns-ap-science-headlines&ctrack=1&cset=true

 

RENO, Nev. — On a farm about six miles outside this gambling town, Jason Chamberlain looks over a flock of about 50 smelly sheep, many of them possessing partially human livers, hearts, brains and other organs.

The University of Nevada-Reno researcher talks matter-of-factly about his plans to euthanize one of the pregnant sheep in a nearby lab. He can't wait to examine the effects of the human cells he had injected into the fetus' brain about two months ago.

"It's mice on a large scale," Chamberlain says with a shrug.

As strange as his work may sound, it falls firmly within the new ethics guidelines the influential National Academies issued this past week for stem cell research.

In fact, the Academies' report endorses research that co-mingles human and animal tissue as vital to ensuring that experimental drugs and new tissue replacement therapies are safe for people.

Doctors have transplanted pig valves into human hearts for years, and scientists have injected human cells into lab animals for even longer.

But the biological co-mingling of animal and human is now evolving into even more exotic and unsettling mixes of species, evoking the Greek myth of the monstrous chimera, which was part lion, part goat and part serpent.

In the past two years, scientists have created pigs with human blood, fused rabbit eggs with human DNA and injected human stem cells to make paralyzed mice walk.

Particularly worrisome to some scientists are the nightmare scenarios that could arise from the mixing of brain cells: What if a human mind somehow got trapped inside a sheep's head?

The "idea that human neuronal cells might participate in 'higher order' brain functions in a nonhuman animal, however unlikely that may be, raises concerns that need to be considered," the academies report warned.

In January, an informal ethics committee at Stanford University endorsed a proposal to create mice with brains nearly completely made of human brain cells. Stem cell scientist Irving Weissman said his experiment could provide unparalleled insight into how the human brain develops and how degenerative brain diseases like Parkinson's progress.

Stanford law professor Hank Greely, who chaired the ethics committee, said the board was satisfied that the size and shape of the mouse brain would prevent the human cells from creating any traits of humanity. Just in case, Greely said, the committee recommended closely monitoring the mice's behavior and immediately killing any that display human-like behavior.

The Academies' report recommends that each institution involved in stem cell research create a formal, standing committee to specifically oversee the work, including experiments that mix human and animal cells.

Weissman, who has already created mice with 1 percent human brain cells, said he has no immediate plans to make mostly human mouse brains, but wanted to get ethical clearance in any case. A formal Stanford committee that oversees research at the university would also need to authorize the experiment.

Few human-animal hybrids are as advanced as the sheep created by another stem cell scientist, Esmail Zanjani, and his team at the University of Nevada-Reno. They want to one day turn sheep into living factories for human organs and tissues and along the way create cutting-edge lab animals to more effectively test experimental drugs.

Zanjani is most optimistic about the sheep that grow partially human livers after human stem cells are injected into them while they are still in the womb. Most of the adult sheep in his experiment contain about 10 percent human liver cells, though a few have as much as 40 percent, Zanjani said.

Because the human liver regenerates, the research raises the possibility of transplanting partial organs into people whose livers are failing.

Zanjani must first ensure no animal diseases would be passed on to patients. He also must find an efficient way to completely separate the human and sheep cells, a tough task because the human cells aren't clumped together but are rather spread throughout the sheep's liver.

Zanjani and other stem cell scientists defend their research and insist they aren't creating monsters -- or anything remotely human.

"We haven't seen them act as anything but sheep," Zanjani said.

Zanjani's goals are many years from being realized.

He's also had trouble raising funds, and the U.S. Department of Agriculture is investigating the university over allegations made by another researcher that the school mishandled its research sheep. Zanjani declined to comment on that matter, and university officials have stood by their practices.

Allegations about the proper treatment of lab animals may take on strange new meanings as scientists work their way up the evolutionary chart. First, human stem cells were injected into bacteria, then mice and now sheep. Such research blurs biological divisions between species that couldn't until now be breached.

Drawing ethical boundaries that no research appears to have crossed yet, the Academies recommend a prohibition on mixing human stem cells with embryos from monkeys and other primates. But even that policy recommendation isn't tough enough for some researchers.

"The boundary is going to push further into larger animals," New York Medical College professor Stuart Newman said. "That's just asking for trouble."

Newman and anti-biotechnology activist Jeremy Rifkin have been tracking this issue for the last decade and were behind a rather creative assault on both interspecies mixing and the government's policy of patenting individual human genes and other living matter.

Years ago, the two applied for a patent for what they called a "humanzee," a hypothetical -- but very possible -- creation that was half human and chimp.

The U.S. Patent and Trademark Office finally denied their application this year, ruling that the proposed invention was too human: Constitutional prohibitions against slavery prevents the patenting of people.

Newman and Rifkin were delighted, since they never intended to create the creature and instead wanted to use their application to protest what they see as science and commerce turning people into commodities.

And that's a point, Newman warns, that stem scientists are edging closer to every day: "Once you are on the slope, you tend to move down it."

* __

 

 

 

Race to Human Stem-Cell Trials
Wired News - Apr 19, 2005

02:00 AM Apr. 19, 2005 PT

SAN DIEGO -- Several scientists have used embryonic or fetal stem cells to help rodents with spinal cord injuries walk again. The researchers travel the country showing videos of rats dragging their hind legs, followed by clips of them miraculously hopping around following stem-cell injections.

The question now, especially in the minds of the 250,000 people in the United States with spinal cord injuries, is: When will the research transfer into helping humans? The answer depends on who you ask. Some scientists believe it could happen as soon as the end of this year. Others say that's too soon, and data from larger animals such as dogs or monkeys is necessary before researching with humans.

 

Evan Snyder of the Burnham Institute in La Jolla, California, is one of those video-toting researchers. Last week at a small stem-cell conference here, he showed the dramatic improvement (.mov) in rats he achieved in 2002.

Despite those positive results with rats, Snyder believes more work must be done before doctors try the experiment on humans. The controversy surrounding embryonic and fetal stem-cell research means the first human clinical trial using the cells will be under a microscope in more ways than one, he said. If something goes awry, opponents of killing embryos for research will be poised to quash future research.

"The last thing we need is another Jesse Gelsinger," Snyder said, referring to the 18-year-old man who died during a gene-therapy trial at the University of Pennsylvania in 1999. After Gelsinger's death, the Food and Drug Administration closed many gene-therapy trials around the country.

Stem cells have the unique potential to self-renew, and to become various cell types. Researchers believe those taken from embryos to be the most flexible kind. Adult stem cells, derived from bone marrow, blood, skin, hair follicles, nasal passages and the brain, come without the ethical quandary, but some scientists doubt they have as much potential as embryonic stem cells.

In 2001, President Bush declared that no federal funds could be spent on embryonic stem-cell lines developed after that date. Since then, many states have taken on funding efforts, but most of the work mentioned in this story was funded privately.

Researcher Hans Keirstead, who also has helped rats with spinal cord injuries to walk again, isn't convinced that primate studies are necessary before testing in humans. Some scientists believe human stem cells are more similar to rodents than monkeys, he said. Keirstead, an assistant professor of anatomy and neurobiology at the Reeve-Irvine Research Center, said he will publish his research soon in a scientific journal.

"Are we going to learn anything from the monkey studies?" he said. "If so, then yes, we should do them. If not, then it's a waste of time and a delay for getting into humans."

Keirstead has been criticized by fellow researchers for hyping his research and moving too fast. But he said patient safety and being honest with patients about potential outcomes are his top concerns.

Geron, a publicly traded stem-cell company, is performing studies that could lead to an Investigational New Drug application with the FDA based on Keirstead's research, which the company funded1. An IND application is the first step to beginning a clinical trial.

Thomas Okarma, Geron's CEO, is even less convinced that larger animals are necessary before testing Keirstead's technique in humans. During an interview at the conference, he said he believes the clinical trial could begin in mid-20062.

Some scientists believe that time frame is too aggressive for the study, which most likely would center on recently injured patients (about a week post-injury), since researchers haven't yet seen success in animals with chronic injuries.

"I think that Geron is offering an optimistic time frame, which is what public companies sometimes do when they haven't ever done a clinical trial before," said Jeanne Loring, adjunct associate professor in stem cells and regeneration at the Burnham Institute.

 

 

 

 

 

The Age of Therapeutic Cloning Dawns

 By Ronald Bailey,  TCS

05-19-05

 

"Humankind has now embarked into the 'Age of Therapeutic Cloning.' This is a scientific revolution of the first rank," asserts Bernard Siegel, executive director of pro-embryonic stem cell research Genetics Policy Institute in a press release. "This is a huge step forward on a par with the first isolation of human embryonic stem cells in 1998," declares, Daniel Perry, president of the Coalition for the Advancement of Medical Research (CAMR).

 

Siegel and Perry are hailing the announcement today in Science by Korean researchers that they have created eleven cloned human embryonic stem cell lines that are matched to eleven individual patients.  This achievement comes only 14 months after the same team of Korean researchers led by Woo Suk Hwang created the first cloned human embryo.  

 

The researchers used somatic cell nuclear transfer (SCNT) to create these cloned human embryonic stem cell lines. They began with 185 eggs donated by 18 women who produced about 10 eggs per induced superovulation cycle. The researchers removed the nuclei from each egg and inserted skin cell nuclei from each patient into the enucleated eggs.  From these 185 eggs, 129 successfully fused with the skin cell nuclei and 31 developed into blastocysts. Eleven different patient matched human embryonic stem cell lines were successfully derived from the 31 blastocysts. The stem cell lines were derived for both males and females and from patients suffering from juvenile diabetes, congenital immunodeficiency disease and spinal cord injuries.

 

Amazingly, Hwang and his team were able to derive stem cells from 34 percent of the cloned blastocysts which is a higher rate than other researchers have been able to derive stem cell lines from donated blastocysts left over from in vitro fertilization efforts. It turns out that eggs donated by women under age 30 work much better for creating cloned blastocysts. Taking into account only those eggs donated by younger women, the researchers conclude, "We have shown the establishment of patient-specific [cloned human embryonic stem cells] with high success rates, i.e., average rates indicating that each oocyte donation cycle leads to the establishment of one patient specific [stem cell] line." In other words, on average, using eggs from donors under age 30, it is possible to create a patient specific stem cell line per each egg donation cycle.  The researchers note, "These rates of [cloned stem cell] establishment, combined with less than one-year timeframe from skin biopsy and oocyte donation to [cloned stem cells], might be clinically relevant if therapeutic cloning were shown to be of medical value." This means that creating transplantable tissues could take less than a year per patient.  

 

Embryonic stem cells have the capacity to perpetually self-renew and to differentiate into any of the more than 200 different cell types that make up the human body. The goal of therapeutic cloning is to produce tissues and organs for transplantation that are perfectly matched to each patient's immune system. The Korean researchers allowed the stem cells to differentiate into various cell types including skin, nerve, kidney and muscle cells.  The stem cells produced by Hwang and his team are immunological matches for specific patients, and that means that if they were transplanted that they would not cause immune rejection. While this research is a tremendous breakthrough, the researchers hasten to point out that it is too early to consider actually transplanting the cells into patients.  First, because some of the cloned stem cell lines carry the defective genes that led to diabetes and immunodeficiency disease. Second, because researchers still have to learn how to safely and stably transform stem cells into specific cell types, say, pancreatic islet cells to treat diabetes.  


This Korean stem cell breakthrough is certain to be a bombshell in the ongoing political debate over human embryonic stem cell research in the United States. In August, 2001, President George W. Bush limited federal funding for human embryonic stem cell research to those cell lines that had already been derived. He argued that this limitation, "allows us to explore the promise and potential of stem cell research without crossing a fundamental moral line, by providing taxpayer funding that would sanction or encourage further destruction of human embryos that have at least the potential for life."  So far only 22 stem cell lines that qualify for federal research funding under President Bush's restrictions are available to American researchers. In response to these federal limitations, various privately funded efforts have been launched and in 2004 California voters approved an initiative to create an Institute for Regenerative Medicine that will spend $3 billion on stem cell research over the next ten years.

 

The House of Representatives has twice voted to criminalize precisely this research, proposing to toss therapeutic cloning researchers into prison for up to ten years and fine them one million dollars.  In fact, if this effort to criminalize research on cloned human stem cells were to succeed, Americans who go abroad to seek cloned stem cell treatments, say, to cure their diabetes, could be jailed for up to ten years for illegally "importing" cloned stem cells.  The Bush Administration was also pushing the United Nations to adopt a treaty to outlaw both cloning to produce transplants and reproductive cloning.

 

The Korean announcement is likely to have a big impact on the upcoming vote in the House of Representatives on the Stem Cell Research Enhancement Act. The House Republican leadership has reluctantly agreed to allow a vote on this bill that would lift President Bush's restrictions and permit federal funding for research on all human embryonic stem cell lines derived from blastocysts leftover from fertility treatments. The bill was jointly introduced by Representative Mike Castle (R-Del.) and Representative Diana DeGette (D-Colo.) and now has 202 co-sponsors. There are 23 co-sponsors in the Senate for an identical bill.  It takes only 218 votes to pass a bill in the House.

 

CAMR's Daniel Perry believes that today's Korean stem cell announcement will increase the pressure in Congress to pass the Stem Cell Research Enhancement Act.  Genetic Policy Institute director, Bernard Siegel, asserts, "The opponents of embryonic stem cell research will be up in arms, but the public is beginning to recognize that the cloning of stem cells is not the same as cloning babies. The opponents' scare tactics will ultimately fail, as we bring this closer to clinical applications."  Here's hoping that Perry and Siegel are right.

 

Ronald Bailey is Reason magazine's science correspondent. His book, Liberation Biology: The Scientific and Moral Case for the Biotech Revolution will be published by Prometheus Books in June. His email is rbailey@reason.com.

 

 

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