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Sightings from The Catbird Seat
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August 13, 2002
Kentucky doctor to try human cloning this year
By Lori Burling, Associated Press
A Kentucky doctor said yesterday that an American couple will be the first of seven to try a controversial human cloning procedure that could give them a baby next year.
Dr. Panayiotis Zavos, of the Andrology Institute of America in Lexington, Ky., and the couple – known only as Bill and Kathy – appeared on “Connie Chung Tonight” last night on CNN.
“The public will realize that this is not as monstrous as … it may sound. Once they see a baby dressed in pink or blue, they will say, “What a wonderful thing,’” said Zavos, a reproductive researcher.
Zavos said he plans to clone a baby for the couple by taking DNA from Kathy and adding it to a donor’s egg. The donor’s DNA would be removed from the egg, which would be implanted into a surrogate mother.
While there is no law specifically prohibiting cloning in the United States, Zavos said the procedures would be attempted later this year in two foreign clinics. He would not disclose the locations.
Bill and Kathy, whose voices were disguised and faces blurred on the show, said they met in 1989, wed in 1993 and immediately began trying to have a baby.
After failed attempts at reproducing the natural way, the couple went to a doctor who recommended artificial insemination. The couple tried that 17 times without luck.
The two then underwent in vitro fertilization, which involves removing an egg from a woman, adding a man’s semen to the egg and then implanting the egg in the woman. That procedure failed to produce a pregnancy in seven attempts. . . .
After their last failed attempt in 1998, Bill and Kathy gave up their dream of having a baby.
However, nearly four years later, the couple read an article on Zavos and his cloning experiments.
“I tracked him down, and I called him, and I called him, and I called him,” Bill said.
Zavos, who owns a conventional fertility clinic in Lexington, is a professor emeritus at the University of Kentucky. He has testified before Congress and the National Academy of Sciences supporting the idea of cloning.
Cloned baby in the dark
Rumour and secrecy hampers response to report of human clone.
by HELEN PEARSON
A dearth of information surrounding claims that a woman is pregnant with the first cloned baby is stifling informed scientific judgement or debate. Second-hand reports and rumours highlight a factual vacuum under which a controversial cloning project is proceeding.
Last week, fertility doctor Severino Antinori revealed to Gulf News journalist Kavitha Daniel that one of his patients is eight weeks pregnant with a cloned embryo. Since then, his clinic and that of his collaborator Panos Zavos at the Andrology Institute of America in Lexington, Kentucky, have refused to confirm or deny the report to the majority of the world’s media.
But Giancarlo Calzolari of Italian newspaper Il Tempo reports that Antinori confirmed the pregnancy to him. Calzolari told Britain’s Daily Telegraph that the procedure was carried out in a Muslim country and that Antinori has sufficient funds to achieve his goal.
Such inconsistencies are typical of the information available on Antinori and Zavos’ contentious programme to clone a human embryo, which they announced last year. How they recruit women to their programme, where the procedures are carried out, and how the plan is funded remain shrouded in mystery.
Without scientific data or publications, scientists are unable to judge the authority of Antinori’s assertions. However, the community widely condemns attempts to carry out cloning for reproductive purposes, because of potential health risks to the embryo.
“I am unaware of a single report by Zavos or Antinori on nuclear transfer in any species, let alone to produce offspring.”
– Tony Perry of Advanced Cell Technology, Massachusetts
“They see it as harmful to the promise of their work in biomedicine,” says Tony Perry of Advanced Cell Technology, a biotechnology company based in Worcester, Massachusetts. Last year, the company announced that it had cloned human embryos to the six-cell stage, but with the aim of creating disease treatments.
What Antinori has attempted or achieved is ambiguous. The technique used to transfer nuclei from an adult cell to an egg stripped of its own DNA is difficult to carry out, even for those with experience, explains Perry. “I am still unaware of a single report by either Zavos or Antinori on nuclear transfer in any species, let alone to produce offspring,” he says.
The furore began at a conference in the United Arab Emirates organized by an intellectual body called the Zayed Centre for Coordination and Follow-up. At the meeting, Antinori spoke generally about his aims and arguments for human cloning for infertile couples.
Antinori revealed that cloning programmes are under way in China and Russia, says Daniel, but only spoke of the pregnancy after the meeting, when she questioned him directly. Members of the public, officials and scientists attended the meeting, but no international cloning experts were present.
Human reproductive cloning is banned in the United Kingdom and many other countries. Like a scientific outlaw, this leaves Antinori to pursue his controversial goals in countries that lack such legislation.
© Nature News Service / Macmillan Magazines Ltd 2002
Doctor vows to clone humans
By August Gribbin, THE WASHINGTON TIMES
An Italian embryologist says he soon will begin helping 200 couples have cloned children, and his claim is reheating and confusing the already fiery debate over cloning.
Dr. Severino Antinori, the scientist who seven years ago helped a 63-year-old woman bear a child, yesterday told participants at a National Academy of Sciences conference here that he would begin the cloning in three months. His American partner, Panos Zavos, told reporters that two cloning labs had been established.
Upon hearing of the announcement, Cardinal Joseph Ratzinger, head of the doctrinal office for the Holy See, told reporters in Rome that Dr. Antinori was trying to “emulate Hitler.”
The cardinal said, “Copying children, for reasons other than treating sterility, is Nazi madness.”
Dr. Antinori earlier told British reporters stationed in Italy that his team of 20 international scientists would use the “somatic cell nuclear transfer” method of cloning — the process employed to produce the first cloned mammal, a sheep named Dolly. For the most part, he said, the couples’ male partners were infertile with “no natural way of becoming fathers.”
He noted the procedures would be performed in some remote country — or in a ship at sea — if hostility to cloning made it necessary.
It well may be necessary.
“The world — including scientists, ethicists and politicians — is united on the notion that we should not bring cloned babies to term,” said biochemist Larry Goldstein, a researcher at the University of California at San Diego.
Human cloning is fraught with difficulties, including the potential for miscarriage, premature delivery and genetic abnormalities.
“The debate over cloning is really a couple of debates, with misunderstandings and complicating nuances that tend to be overlooked,” Mr. Goldstein said.
He was reacting to action in the U.S. House last week.
After a limited but widely watched floor argument, the House passed a measure outlawing cloning techniques to create identical copies of humans.
A spokesman for the Austrian Embassy said the news “was a same-day, front-page story” in his country and throughout Europe “because cloning is a matter of intense interest worldwide.”
What made it more interesting to most observers was that the House also outlawed the use of so-called “therapeutic cloning” to produce tissue that could be used to treat diabetes and other ailments that now have no cure.
Violators would be subject to a 10-year prison term.
Nuclear transfer, the most successful and best-known cloning technique, would violate the ban.
Under that procedure, the nucleus of the egg, which contains genetic matter, is extracted and a somatic cell is inserted in its place. A somatic cell is nonreproductive, like a skin cell.
The transformed egg then is subjected to electric current. That fuses the cell to the egg’s membrane, and causes the egg to absorb the cell’s nucleus and genetic material. The reaction mimics conception.
To create a cloned animal — including a human — the egg, which now acts like an elemental embryo, must be transplanted into a female — a surrogate mother.
Therapeutic cloning follows the same procedure. The nuclear transfer is accomplished on a human egg, creating the embryo. But the egg is not planted into a surrogate. Shortly after the embryo starts growing in the lab, stem cells from the embryo are removed to be used for research and eventually as therapies for now-incurable ailments like Alzheimer’s or Parkinson’s disease.
Medical researchers believe that a human body may reject stem cells that are injected to cure disease. If so, treated patients will be required to take anti-rejection drugs interminably.
However, if the patient contributed the cell that replaced the egg’s nucleus in the cloning process, the patient in effect would be receiving part of his own body. That, according to the rationale for therapeutic cloning, would pose no fear of rejection and no need for anti-rejection drugs or risk of drug reaction.
Still, many fear that allowing therapeutic cloning — for curing diseases and eradicating stem-cell rejection — would open the door to abuse.
Indeed, Dr. Antinori and several other scientists insist they won’t be deterred from cloning, despite the ban.
During the debate in the House, Rep. Louise M. Slaughter, New York Democrat, argued against a ban on therapeutic cloning, saying: “We must not allow our fears about research to overwhelm the hope for curing disease. We must not isolate this nation from the rest of the scientific world.”
With the exception of Great Britain and Japan, no developed nations allow therapeutic cloning — although most are debating the issue. “We’re watching the United States. They’re the leader in this,” said a spokesman for the Australian Embassy. . . .
The House measure has moved to the Senate for debate, which promises to be fierce.
Cloned baby row doctor ‘has run out of patients’
By Roger Highfield, Science Editor
DR SEVERINO ANTINORI, the fertility doctor who wants to create the first cloned baby, has no clones, no laboratory, no patients and no doctors to help him with his programme, according to his former partner.
It marks the latest twist in a controversy that has raged since Dr Antinori and Dr Panayiotis Zavos disclosed their plans on Jan 23, 2001.
The secret programme had been taken over by Dr Zavos, president of Zavos Diagnostic Laboratories, a firm based in Kentucky that markets infertility products and technologies, it was claimed yesterday.
Dr Zavos said Dr Antinori had no team. “The team that we had together is all with me,” he said. “The patient list is ours. It is in my computer.”
Dr Zavos said he would “definitely” attempt the first human cloning before the end of the year.
“Last year, our team made it into an issue,” he said. “This year we will make it into a reality.”
Earlier this week, Dr Antinori told Italian state television of three cloned pregnancies, two in Russia and one in an “Islamic state”, that are six to nine weeks in gestation.
But Dr Zavos said the statement was inaccurate. “I know this group in Russia. They don’t have a pregnancy.”
As for the Islamic group, “the Islamic world would not allow that to happen”, he said. . . .
The effort to clone a human was based at two laboratories, said Dr Zavos. He refused to disclose where the laboratories were based, but he said they did not include England, France, Italy, Greece or Cyprus. “They are in this world. That is the location.”
Because Dr Zavos was awarded an honorary professorship by the Chinese Academy of Science, there has been speculation that China is hosting one of the human cloning laboratories.
Dr Zavos also refused to identify his researchers, save to say that they were “the Michael Jordans of the business”.
His team was “based all over the world. We are en route to putting together the package that we promised”.
He referred to the original claim that the birth of a clone would take 18 to 24 months.
“We are not in the business of delivering a pizza,” he said. “Beating the clock is not one of our goals. Doing it right is more important.”
The privately funded teams have been perfecting cloning in experiments on cattle and mice that started “years ago”. However, he declined to describe the numbers of animals that had been cloned, save that the animals were “all healthy”. Instead of giving his team’s success rate, he quoted a four-year-old paper on cloning goats that cited a success rate of 32 per cent, which is better than with test tube baby technology.
The team “does not intend to experiment on human embryos”, he said.
Instead, he said that cloning technology, when ready, would be applied directly to achieve a pregnancy without any dry runs.
There were detailed arrangements to put a dozen or so couples “in nice hotels”, ensuring that they were comfortable, arranging visas and finding a supply of human eggs. None of the couples was British.
The couples would cover the costs, he said.
They would also sign a consent form that would allow an abortion if the cloning goes awry, which he said was standard with reproductive science.
First cloned baby is the son of rich Arab, says doctor
By Bruce Johnston in Rome and Lorraine Fraser
THE world’s first cloned human embryo is the son of a rich Arab, according to claims made by Severino Antinori, the Italian fertility specialist.
Dr Antinori said that the embryo was the clone of a VIP and that he had been experimenting to produce human clones “in an Islamic country”.
The doctor, who pledged with Panos Zavos, of the Andrology Institute of America in Lexington, Kentucky, to attempt to clone a baby by the end of 2001, caused outrage last week when he told a scientific meeting in the United Emirates that a woman patient was eight weeks pregnant with a clone.
His claim has met with disbelief from infertility specialists worldwide, coupled with concern that such a pregnancy could result in a severely malformed baby, as has been the case in animals.
Dr Antinori, however, has told Giancarlo Calzolari, a friend and science reporter at Il Tempo newspaper in Rome, that the pregnancy is real and that he has a “limitless supply of money” for his experiments. . . . Arab
“He told me it was a clone of an important, wealthy personality,” Mr Calzolari said. “However, he was vague when I asked him the name of the woman and to at least describe the father. He would only say that he was a grosso personaggio [a big cheese].
“The doctor added, ‘I have at my disposal whatever amount of money is needed to reach the result. Imagine, it has been possible to carry out in a Muslim country a kind of research that was impossible to do in the West.’ “
Dr Antinori has also dismissed concerns about malformations, claiming that it was a “certainty” that the problems seen in other cloned animals did not occur in human beings, Mr Calzolari said.
All the embryos implanted during the programme were examined, reducing “almost to nothing” the risk of malformations. A leading Arab infertility specialist said last night that he was highly sceptical of Dr Antinori’s claim of working in an Islamic country.
Samir Abbas, the president of the Saudi Arabian Fertility Society, said the religious authorities had ruled against the procedure a long time ago and that anyone involved would face heavy sanctions.
The woman’s treatment could not have been carried out in his country, he said. “We are absolutely against it until all the world agrees this is a safe method.”
Dr Antinori, who runs a clinic in Rome, is well-known as a man prepared to cross ethical boundaries. He helped a mother of almost 63 to have a child after her adult son died and caused outrage in Britain six years ago when he helped an unmarried woman of 59 to have twins.
According to Gulf News, Dr Antinori told delegates at the meeting in Abu Dhabi that “like atomic energy” cloning could be used for “beneficial purposes – to increase population and open the window of genetic programming“.
© Copyright of Telegraph Group Limited 2002.
Dolly’s doctors hit cloning of humans
By Alasdair Palmer, LONDON DAILY TELEGRAPH
LONDON — The doctors responsible for cloning the sheep Dolly say they are outraged by scientists who plan to press ahead with attempts at human cloning, calling any such attempt intolerable.
Dr. Severino Antinori, an Italian gynecologist, and Dr. Panayiotis Zavos, an American “andrologist,” announced last week that they would start work on creating the first human clone “in the next 30 to 60 days.”
They insisted that the first cloned human baby will be born next year.
But Ian Wilmut, the scientist who stunned the scientific world by leading the effort that produced Dolly, said in an interview: “To try cloning on humans today would be criminally irresponsible. The problems are far too serious.” . . .
The majority of cloned animals have something wrong with them. They die in the womb, or soon after birth. Typical defects are malfunctioning lungs, a heart that doesn’t work as it should, an imperfect immune system and abnormal size.
The scientists have theories about why so many clones seem to go wrong. One is that molecules attached to the genetic material which are important in ensuring that only some genes are “switched on” at any given location in the body (so that, for instance, your brain cells are in your head, rather than in your stomach), are scraped off or damaged when the cell to be cloned is manipulated by the experimenters. Manipulation by experimenters is inevitable, not just when DNA is removed from the egg, but also when the new cell is inserted into it.
The process disrupts development in other ways. Kevin Eggan, a professor at the Whitehead Institute for Biomedical Research at the Massachusetts Institute of Technology, said that even when they look normal, many cloned animals have damaged or imperfectly copied genes, which, in people, could result in serious mental problems.
“Disruption of those genes in humans,” he said, “could cause retardation, among other difficulties.”
Dr. Rudolph Jaenisch, a colleague of Mr. Eggan’s, cautioned that there are between 30,000 and 40,000 genes in the human genome.
“Any one of them is, in principle, a target for faulty programming in the cloning process. We have no idea how many are adversely affected by it, and there’s no way at present to find out. Tiny copying errors can have horrible consequences.”
© Copyright of Telegraph Group Limited 2002.
Scientists successfully clone first domestic pet
By Rick Weiss, The Washington Post
Scientists in Texas have created the first cloned cat, a domestic calico named “cc” that has immediately taken a curious and controversial place in history as the first cloned domestic pet.
Born Dec. 22 by Caesarean section in a university laboratory, the apparently healthy cat is the sixth kind of mammal to be created asexually from a single adult cell – after sheep, mice, cattle, goats and pigs – and the first “companion animal” to be cloned.
Scientists said the ability to clone cats could eventually be a boon to biomedical research, but more immediately could satisfy what they said was a growing consumer demand for pet cloning services.
“You can’t beat around the bush. There are lots of people interested in their pets, so why avoid it?” said Mark Westhusin, the lead scientist behind the project at Texas A&M University’s College of Veterinary Medicine in College Station.
The feat drew criticism from animal-care groups, which have spearheaded efforts to reduce feline birth rates.
“Isn’t it crazy that millions of animals are killed in shelters in this country every year and people are thinking so selfishly about cloning more of them?” said Mary Beth Sweetland, vice president of People for the Ethical Treatment of Animals in Norfolk, Va.
The work was funded by Arizona millionaire John Sperling, who has given Texas A&M about $3.7 million to develop technology to clone his beloved dog, Missy.
Although several pregnancies have been achieved, no Missy clones have survived.
Parallel work on cats went faster, Westhusin said, in part because cat eggs grow and mature in culture dishes better than dog eggs….
O O O
Apollo Group CEO John Sperling Looks to Broaden Boundaries of Higher Education
Excerpts from an Interview on CNN’s Pinnacle, Aired July 16, 2000:
BEVERLY SCHUCH, HOST (voice-over): John Sperling is about living, reborn several times after close brushes with death. In fact, he’s a lot like the mythical bird the phoenix, having risen from the ashes of his own adversity. He was born the son of an impoverished sharecropper who beat him regularly. As a youth, he worked the farms in the Ozark Mountains shucking barley. He didn’t learn to read until he was 16. He faced bankruptcy twice and cancer once.
But John Sperling is a fighter and has overcome these hardships to soar to the highest level of entrepreneurial success.
JOHN SPERLING: Fortunately, there were no orders governing institutions of higher education so all I did was start a corporation and name it the University of Phoenix.
SCHUCH: (Voice-over) All John Sperling did was create what has become the lawmaking unit’s largest for profit university and certainly the most unusual. Its 74,000 students must hold full-time jobs. Its 52 campuses in 35 states are actually housed in office buildings and there are no dorms, no student unions and certainly no football teams. But the unusual university that John Sperling created in 1978 has become the talk of higher education, not all of it flattering.
While his peers criticize Sperling’s concept, they can’t argue with his credentials, including Ph.D. from Cambridge University.
(on camera): You were originally criticized as being a diploma mill.
JOHN SPERLING: A diploma mill.
SCHUCH: A diploma mill.
JOHN SPERLING: Right.
SCHUCH: Just giving them out without accreditation, without any foundation.
JOHN SPERLING: Yes. Yes. That’s true.
SCHUCH: And what did that make you think?
JOHN SPERLING: Well, the thing that helped a lot is that because I was a legitimate academic, it was difficult. They couldn’t say that I wasn’t an academic. They just said that I was a rogue academic.
SCHUCH (voice-over): But Sperling defied the educational establishment that tried to run him out of town.
JOHN SPERLING: I had students but no college so I set up the University of Phoenix.
SCHUCH (on camera): Who wouldn’t have thought that there wasn’t a University of Phoenix? I mean you came in and invented it.
JOHN SPERLING: Yes.
SCHUCH: People could not have been happy about that.
JOHN SPERLING: Well, they weren’t happy. They were incensed that this California carpetbagger had come down here and stolen the name of their fair city.
SCHUCH (voice-over): It took a while, but Sperling is gaining the grudging respect of his peers and the not so grudging respect of Wall Street, after the University of Phoenix reported revenues of a half a billion dollars last year. The parent company, Apollo Group, is doing even better.
JOHN SPERLING: We took the company public and the IPO, the stock increased by 20 times and I was holding, my son and I were holding a third of the company or nearly 40 percent of the company. We don’t own that much anymore, but we own about 30 percent. But 30 percent of $2 billion is a lot of money.
SCHUCH: Sperling has used his newfound wealth to pursue a grab bag of causes, from prolonging human life to legalizing marijuana to feeding the world.
UNIDENTIFIED COLLEAGUE: Dr. Sperling, you’re making one hell of a contribution.
SCHUCH (on camera): You have a lot of money now.
JOHN SPERLING: Yes.
SCHUCH: You have a son…
JOHN SPERLING: … who also has a lot of money.
SCHUCH: Who also has a lot of money. What are you going to do with all this money?
JOHN SPERLING: I’m starting, as you know, drug order reform is very expensive. It costs millions of dollars a year.
SCHUCH: So this is your indulgence?
JOHN SPERLING: Yeah, that’s one of them. And then two other indulgences, Seafire International, which is a saltwater agricultural company that is one day going to save the world, I might add…
SCHUCH: Modestly.
JOHN SPERLING: … by stopping the global warming problem. And then I have Chronos, which I’m trying to use as an instrument to reform medical practice in the United States. . . .
SCHUCH (voice-over): Sperling’s interest in drug reform was at least partly inspired by his use of marijuana during treatment for prostate cancer. As with the other passions in his life, Sperling has attacked the marijuana issue with a vengeance, teaming up with Cleveland businessman Peter Lewis and hedge fund billionaire George Soros. . . .
SCHUCH (voice-over): And that’s not all. At age 79 and still going strong, John Sperling has a great many other causes to fight for, including finding the fountain of youth. . . .
SCHUCH (on camera): What’s the worst thing one can feel?
JOHN SPERLING: Boredom. And that in its most extreme form would be depression.
SCHUCH: Do you understand happiness?
JOHN SPERLING: No. I never thought of being happy. I’ve never sought happiness. It’s not something that concerns me.
SCHUCH (voice-over): What does concern John Sperling these days, he says quite humbly, is saving the world. He’s teamed up with scientist Cora Hodges to form Seafire International, a company designed to harvest a crop called salacornea grown in salt water. Sperling sees this project as a lifeline for poor economies.
JOHN SPERLING: The sea water farms are going to be an essential element in, you might call, the economic recovery of both Eritrea and Ethiopia.
SCHUCH: And if you want to save the world, then you’d better plan to be around for a while. . . .
SCHUCH: That’s why John Sperling also created Chronos, named for the Greek god of time, a wellness center that combines vitamin therapy with extensive body and blood analysis to help forestall the aging process. And beyond improving the condition of mankind, Sperling’s latest challenge, the cloning of animals.
JOHN SPERLING: That’s another company I’ve started, Genetic Savings and Clone.
SCHUCH (on camera): You’re kidding, right?
JOHN SPERLING: No. We already have a cryo bank for DNA for all sorts of animals. We intend to start a cloning service to clone pets and farm animals.
SCHUCH: And why?
JOHN SPERLING: Because it’s possible. There are all sorts of reasons to do it. In addition to one of a kind animals, there are, you can help to recover species that are endangered with extinction. You can do transgenic work with farm animals and create all sorts of medicines for human beings.
SCHUCH: And you would want to make money out of this?
JOHN SPERLING: Oh, we will make money. We’ll make a lot of money at it. . . .
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For much more on John Sperling, GO TO > > > Songs of the Drug Vultures
From Advanced Cell Technology press release:
ADVANCED CELL TECHNOLOGY REPORTS PUBLICATION OF RESULTS OF HUMAN SOMATIC CELL NUCLEAR TRANSFER AND PARTHENOGENESIS
— Important Milestone in Therapeutic Cloning–
Worcester, MA — Advanced Cell Technology, Inc. (ACT) today announced publication of its research on human somatic cell nuclear transfer and parthenogenesis.
The report, published in today’s Journal of Regenerative Medicine, provides the first proof that reprogrammed human cells can supply tissue for transplantation.
Human embryonic stem (ES) cells, and other cells derived from the inner cell mass of the preimplantation embryo are totipotent, that is, they are capable of forming any cell or tissue in the human body. While numerous human ES cell lines are now in existence, they are of little value in human transplantation, as they would be rejected by a patient as foreign.
Human therapeutic cloning has the potential to solve this problem by providing cells that are an exact genetic match for the patient.
ACT’s paper reports preliminary studies on two means of manufacturing such cells. The first method is parthenogenesis. In this technique an egg cell is activated without being fertilized by a sperm cell. A patient in need of a particular cell or tissue type provides the egg cell, the activated egg cell forms a preimplantation embryo, and the resulting stem cells are differentiated into the type of tissue the patient needs. The paper reports success in activating egg cells in this manner to form many-celled embryos resembling blastocysts. The paper does not report data on stem cell isolation.
In a second series of studies, the company performed somatic cell nuclear transfer (cloning) to form preimplantation embryos. In this instance, human egg cells were prepared by removing their DNA and adding the DNA from a human somatic (body) cell. The paper reports that the somatic nuclei showed evidence of reprogramming to an embryonic state as evidenced by pronuclear development (a type of nucleus observed only in the fertilized egg) and by early embryonic development to the six-cell stage. Again, the company did not report on stem cell isolation.
“Our preliminary results add to the weight of evidence that human cell reprogramming is possible,” said Jose B. Cibelli, Ph.D., D.VM., Vice-President of Research at ACT and the first author of the report. “We understand that these are early and preliminary results, but given the importance of this emerging field of medicine we decided to publish our results now.”
The company’s goal in applying cloning to human medicine is to create stem cells capable of differentiating into a variety of cells, such as heart cells, neurons, blood cells or islets for transplant therapies. “These are exciting preliminary results,” said Robert P. Lanza, M.D., Vice President of Medical and Scientific Development at ACT and an author on the paper.
“This work sets the stage for human therapeutic cloning as a potentially limitless source of immune-compatible cells for tissue engineering and transplantation medicine. Our intention is not to create cloned human beings, but rather to make lifesaving therapies for a wide range of human disease conditions, including diabetes, strokes, cancer, AIDS, and neurodegenerative disorders such as Parkinson’s and Alzheimer’s disease.”
“Human therapeutic cloning could be used for a host of age-related diseases,” said Michael D. West, Ph.D. the company”s CEO and an author of the paper, “”if the human cells behave as animal cells have in previous studies, we may have found a means of rebuilding the lifespan of cells at the same time. This would allow us to supply young cells of any kind, identical to the patient, that could be used to address the tidal wave of age-related disease that will accompany the aging of the population.”
Researchers from Advanced Cell Technology collaborated with scientists from Duncan Holly Biomedical of Somerville, Massachusetts on the paper. The other authors are Kerrianne Cunniff of ACT, and Ann A. Kiessling and Charlotte Richards.
Advanced Cell Technology is a biotechnology company focused on discovering and developing cloning technology for human medicine and agriculture.
OFFICERS
Michael D. West, Ph.D.
President & Chief Executive Officer – Dr. West received a B.S. degree from Rensselaer Polytechnic Institute in 1976, his M.S. in Biology from Andrews University in 1982, and his Ph.D. from Baylor College of Medicine in 1989. He has extensive academic and business experience in age-related degenerative disease, telomerase molecular biology, and human embryonic stem cells. From 1998-1999 he was a Co-founder and Chairman of Origen Therapeutics of South San Francisco, California, a company developing transgenic technology in commercial poultry. From 1990 to 1998 he was the founder, director and Vice President of Geron Corporation of Menlo Park, California, where he initiated and managed programs in telomerase diagnostics, telomerase inhibition, telomerase-mediated therapy, and human embryonic stem cells.
Jose B. Cibelli, D.V.M., Ph.D.
Vice President of Research – Dr. Cibelli received his D.V.M. in Veterinary Medicine at the University of La Plata, Argentina in 1989, and a Ph.D. from the University of Massachusetts in Amherst in 1998. From 1989 to 1993, he was a Veterinarian at the Cooperative of Artificial Insemination of Venado Tureto, Argentina, and has several years of research experience at the Department of Veterinary and Animal Science at the University of Massachusetts Amherst, where he did his doctoral dissertation (in the laboratory of James Robl) on the production of transgenic cattle. Dr. Cibelli is one of the pioneers in the area of cloning with transgenic somatic cells in bovine for the production of animals and embryonic stem cell-like cells. His work was focused in the production of transgenic cattle. In January 1998, Dr. Cibelli’s efforts lead to the announced the generation of the world’s first transgenic calves by cloning. . . .
Robert P. Lanza, M.D.
Vice President of Medical & Scientific Development – Dr. Lanza is a former Fulbright Scholar and has been nominated for a MacArthur Foundation “genius” award. . . .
Robert H. Saglio
Chief Operating Officer – He was one of the principal founders of Avian Farms, Inc., a poultry genetics and breeding company, and one of the founders of ACT.
Gunnar L. Engstrom, MBA
Chief Financial Officer – a former Director and Chairman of the Finance Committee of ACT Group. Mr. Engstrom was a Director of ATP Capital LP, a private equity fund dedicated to the field of life sciences, prior to joining ACT Group. Prior to ATP Capital LP, Mr. Engstrom spent seven years as a management consultant with McKinsey and A.T. Kearney. He holds a B.S. in Finance from Drexel University and an MBA from Harvard Business School.
WEIRD SCIENCE!
Few people in the U.S. are aware that a truly “watershed achievement in biotechnology” occurred in Nov of 1998, according to British media sources, when “American Cell Technology (ACT), a leading private biotechnology company cloned the first human embryo and let it develop for 12 days before destroying it.“
This remarkable, though rather dubious, achievement was accomplished “using a cell from a man’s leg and a cow’s egg,” and is believed to be only the first of many “human embryos that have been created and destroyed since November.”
Already there is a competitor in the field as well, as “another U.S. company, Geron, is also reported to be attempting to clone human embryos.”
You might think that these would be newsworthy events, particularly in the country pursuing this research, but you would be mistaken. You might also think that human cloning was banned in the U.S., but again you would be mistaken. As it turns out, “Therapeutic cloning of humans is illegal in Britain, though not in the United States,” where it is also apparently not a matter for public debate. [Another “Don’t Ask, Don’t Tell” policy?]
These are not, mind you, actual people that are being created and destroyed, but “therapeutic clones.” Therapeutic clones are grown … as a source of tissue in an attempt to create human “stem cells,” or “master cells,” for use in transplantation and treatment of disease.
So these are actually just collections of human embryonic tissue that roughly approximate the shape of an actual human. Besides, the clones are only grown for 12 days and ACT’s Director of Tissue Engineering assures us that “the embryo cannot be seen as a person before 14 days,” that being the age at which the embryo would implant itself onto the wall of its mother’s womb.
Some people believe that life begins at conception, while others believe it begins at birth. But now we know that life actually begins at 14 days, and we know this because no less an authority than the Director of Tissue Engineering has said it is so.
And, of course, there is no reason to doubt the company’s sincere assurances that it actually is destroying all their little creations, though one is prone to wonder exactly whose leg it is that provided the cellular material being utilized to create these clones. . . .
U.S. to Allow Research on Embryo Cells
Associated Press
President Clinton today touted new federal guidelines allowing scientists to conduct federally funded research on cells taken from human embryos, saying they offer “potentially staggering benefits.”
The guidelines for the research are vehemently opposed by anti-abortion groups. The guidelines set out the criteria the National Institutes of Health will use to consider applications for federal grants to study embryonic stem cells . . .
Experts believe the cells could be invaluable in treating many serious diseases, such as diabetes and Alzheimer’s. But some oppose the research on grounds that to get the cells, scientists must destroy human embryos. . . .
Clinton said it would deal only “with those embryos that are collected in in-vitro fertilization.”
The research involves what are called pluripotent stem cells, the foundation cells that give rise to all of the other cells, tissues and organs in the body.
Opponents threatened to stop the effort. “I don’t think that they, by law, should be allowed to do this,” said Rep. Jay Dickey, R-Ark.
“We’re talking about dismembering a living being, according to our interpretation,” said Dickey, who has introduced legislation banning the destruction of human embryos.
CLONING UNSAFE, UNIVERSITY OF HAWAII TEAM WARNS
They’ve found hidden problems among mice that they’ve cloned at the university
by Helen Altonn, Honolulu Star-Bulletin
University of Hawaii researchers who pioneered a mouse-cloning technique warn that cloning humans and animals with embryonic stem cells isn’t safe.
They’ve discovered in their work with mice that cloned pups have hidden problems.
“Even if a cloned animal looks normal, it may have a dormant problem,” said Ryuzo Yanagimachi, professor of anatomy and reproductive biology, who directs the Institute for Biogenesis Research in the John A. Burns School of Medicine.
He also urges caution in potential use of embryonic stem cells to treat degenerative illnesses because of tissue culture problems….
He participated in two studies expected to create waves among scientists seeking to clone animals or use embryonic stem cells for therapeutic reasons.
“Many people studying DNA might be shocked,” Yanagimachi acknowledged.
The findings are the latest in a controversial research area. President Bush supports a bill that would prohibit creation of cloned embryos for research use despite scientific arguments about the lifesaving potential.
Yanagimachi’s team works only with mice but some mainland scientists are culturing stem cells from surplus embryos donated by fertility clinics or from aborted fetal tissue.
Other researchers are working on techniques to use stem cells from skin tissue, bone marrow or umbilical cord blood.
Yanagimachi and Dr. Hidenori Akutsu, a “Team Yana” member, collaborated with Rudolf Jeanisch and scientists at Whitehead Institute, Massachusetts Institute of Technology, in research being reported in tomorrow’s issue of Science. . . .
“A few years ago people dreamed of fantastic cell beauty in the future,” said Akutsu, research fellow in the biogenesis institute and a doctor in the Department of Obstetrics and Gynecology at Fukushima Medical University in Japan .
“Our paper shows we must be more careful. Cloning will never make a correct copy. Especially in the beginning stage, it is very unstable.” . . .
Steve Ward, associate professor in the biogenesis institute, and Stefan Moisyadi, research coordinator, joined Yanagimachi and Akutsu in discussing the two papers in an interview. . . .
Cloned mice aren’t perfect copies of the original mice, the researchers found.
They reported in Genesis that many cloned animals have abnormal symptoms at birth, such as “overgrown placentas, increased body weight and respiratory problems.”
Some die of hematological or immunological problems before reaching adulthood, they said.
They believe the problem lies in the DNA methylation pattern.
Methylation is the process of molecularly flagging a cell’s genes so they are expressed in the right place at the right time to do what they are supposed to do, the researchers explained. Aberrant DNA methylation also can turn off genes and cause defects, according to research by Ohio State University scientists published in the journal Nature Genetics.
Yanagimachi and Akutsu and their colleagues found the methylation pattern isn’t stable in clones of embryonic stem cells and can cause health problems. Both research papers indicate methylation patterns change, mainly in the tissue culture even before cloning, Moisyadi noted.
The researchers examined DNA of the placenta and skin of cloned mouse fetuses right before birth and several were incorrectly methylated. Each animal had different abnormalities. Molecular changes occur even in clones from normal cells, Ward said.
“No matter what you do, cloning changes these methylation flags. That’s the important thing about cloning,” he said. “The first problem was that somehow the mice were fat. That was the first hint that there was change.
“The second change that we suspected, and has been proven twice, is there are many changes in methylation, which is the way DNA is regulated by the cell.”
The cloning technique is very inefficient now, with 98 percent of embryos dying, Yanagimachi said.
“It is very likely that the vast majority of cloned embryos die of extensive errors in DNA methylation.
“The one born is an exception, and even with one we may see some problems. It may not be perfectly normal.
“We don’t know if we can ever make this cloning safe,” Yanagimachi added.
“We don’t know. We’re hoping. Even if cloning becomes safe, it is not for humans. Even for animals, it is not safe.”
“A mouse only lives two years; humans 80 years,” Ward pointed out, emphasizing the potential of dormant defects in cloned animals.
Since abnormal DNA methylation is known to cause developmental abnormalities and diseases, Yanagimachi said, “It is of primary importance to find a way to eliminate or minimize faulty DNA methylation in cloned offspring, regardless whether cloning is used for reproductive or therapeutic purposes, including cell, tissue and organ replacement therapies.”
“Team Yana” has been trying to improve the efficiency of cloning since making international headlines in 1998 with the historic cloning of five generations of female mice.
But the “Honolulu Technique” didn’t work after the fifth generation.
The team cloned the first male mouse, Fibro, and has made advances in understanding fundamental questions about biological development.
Yanagimachi also is noted for his work in in-vitro fertilization and freeze-dried sperm technology. He was recently elected to membership in the elite National Academy of Sciences in recognition of his achievements.
Flaws Found in Cloned Mice Grown Using Stem Cells
The Associated Press
Researchers have found serious abnormalities in cloned mice, a finding that strengthens the belief of many scientists that the technique used to clone Dolly the sheep should not be used on humans.
The findings are based on the use of embryonic stem cells in cloning and come as the Bush administration considers whether to allow federal funds (a.k.a. US taxpayer’s money) for non-cloning stem cell research. . . .
“This study confirms the suspicions of many of us that cloning of humans would be really dangerous,” said Rudolf Jaenisch, senior author of the study and a researcher at the Whitehead Institute for Biomedical Research and at the Massachusetts Institute of Technology. . . .
In cloned humans, Jaenisch said the gene expression flaws could affect personality, intelligence and other human attributes….
Dr. David Prentice, an Indiana State University professor of life sciences, said the MIT-Whitehead study shows the hazards of the current cloning technology.
“Development is a finely orchestrated ballet of cells forming tissues and organs at the right place and time,” said Prentice. “It takes only one going awry at the wrong time and place to have a seriously flawed individual.” . . .
The researchers monitored the expression, or action, of genes that play a role in embryo and fetal development. They found that the genes, even from nearly identical stem cells, worked differently. In fact, said Humphreys, stem cells are unstable in gene expression even in the laboratory dish.
This instability raises the possibility that using stem cells to treat health disorders may not work as well as some scientists have suggested, said Dr. Joann Boughman, vice president of the American Society of Human Genetics. . . .
New Rules on Use of Human Embryos in Cell Research
The New York Times
The National Institutes of Health issued long-awaited rules yesterday that would permit federally (aka US taxpayer) financed researchers to work on human embryonic stem cells….
Opponents of abortion have objected to federal approval of such research because the embryos, which they consider to be capable of life, are destroyed in the process….
In an attempt to sidestep the abortion issue, the National Institutes of Health would allow its researchers to use only cells that were obtained by private firms. The agency’s researchers themselves would not be allowed to extract the cells from discarded embryos.
The cells may legally be derived by anyone who does not receive federal financing. Human embryos are created by mixing eggs and sperm in fertility clinics….
President Clinton, in a press conference yesterday, referred to the “potentially staggering benefits of this research.”
“I think we cannot walk away from the potential to save lives and improve lives, to help people literally get up and walk, to do all kinds of things we could never have imagined,” the president said, “as long as we meet rigorous, ethical standards.”…
Senator Sam Brownback, Republican of Kansas, the Senate’s leading critic of the agency’s policy, said in a statement yesterday that human embryonic stem cell research was “illegal, immoral and unnecessary.”
Mr. Brownback said the research was prohibited by a Congressional ban on financing research that led to the destruction of human embryos, that sought to benefit by taking human life, and that would lead to treatments that can be developed by other means: the use of adult stem cells.
One new issue that has been raised in recent months comes from the finding that a different kind of stem cells found in the organs of adults are far more versatile than supposed. The opponents of financing embryonic stem cells have argued that the promised health benefits could be obtained just as well from a patient’s own adult stem cells….
Use of a patient’s own stem cells would avoid both the ethical problems of embryonic stem cells and the threat of immunological rejection….
Last week a scientific committee recommended to the British government that researchers should be allowed to embark on therapeutic cloning, in which an ordinary body cell is taken from a patient and inserted into a human egg cell whose own nucleus has been removed.
In principle, the inserted nucleus can then direct the egg to grow into an entire adult organism. This is the process that was used to clone Dolly the sheep….
A human egg cell with an introduced adult cell nucleus would presumably be a viable embryo, but inserting it into a uterus would be a criminal offense in Britain. For therapeutic cloning, the egg would instead be cultured in laboratory glassware and exposed to signals that would convert it into the type of tissue that the patient needed to have replaced….
In the United States therapeutic cloning could legally be undertaken by private researchers but no-one is known to have done so, Dr. Lana Skirboll, director of science policy at the National Institutes of Health said. . . . [Apparently she didn’t read the British newspaper report about American Cell Technology.]
Therapeutic cloning is specifically prohibited for federally financed researchers by the guidelines issued today….
* * *
It now appears that Senator Sam Brownback was on the right track:
Associated Press, 11/6/00: Cadaver Tissue May Replace Fetal Tissue. . . . Scientists create brain stem cells from cadavers; it may be an alternative to using fetal cells.
Scientists have coaxed new life out of dead brains. It turns out that even cadavers can supply the incredibly versatile brain stem cells — master cells that can turn into different kinds of brain and nerve cells — once thought available only from fetal tissue.
So can skin. And it appears that just about every bone stem cell can be tweaked to produce brain cells….
(And the latest: Ordinary human FAT CELLS can supply these stem cells. And there’s no shortage of these around! For FREE!)
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Last update January 22, 2003, by The Catbird