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July 13, 2001 Human Embryo Cloning Experiment Involves Ethicists and Bodyguards By ANTONIO REGALADO Staff Reporter of THE WALL STREET JOURNAL WORCESTER, MASS. -- In laboratories on the grounds of a drab office park here, a scientist is preparing to do what many consider the unthinkable: produce the world's first-ever cloned human embryo, a microscopic, 100-cell version of an already living person. The scientist, Michael West, is chief executive of Advanced Cell Technology, which quietly began preparations for the experiment in September when it placed newspaper ads seeking women to serve as egg donors. Dr. West says the company now has eggs in hand and will soon use a technique similar to that which produced Dolly, the cloned sheep, to create tiny human embryos that are genetic twins of existing people. Advanced Cell won't use the cloned embryos to create identical humans; rather, it plans to extract their stem cells, a process that destroys the embryos. In recent experiments, scientists are showing that these specialized cells can be coaxed to grow into human tissues that could help treat a host of diseases. To some, the scenario unfolding at Advanced Cell's labs is drawn from a horror film -- nascent human lives, created by cloning, used as fodder for high-tech tissue factories. In fact, there are several bills in Congress to outlaw the birth of humans through cloning -- and one bill would even criminalize cloning for research, threatening scientists like Dr. West with 10 years in prison. But to Dr. West and others, the cloning experiment is a gateway to great new cures, lucrative patents -- and, perhaps, a measure of immortality. "This isn't scientists gone crazy, doing whatever they can do. There is a purpose and meaning behind it," says Dr. West, who is 48 years old. "Our goal is to demonstrate that we can create transplantable cells and tissues via cloning." The hotly debated technique being proposed is called "therapeutic cloning." By combining an adult's cell -- usually skin, but any cell will do -- with an unfertilized human egg, Dr. West and other researchers say they can create an embryonic twin of any person. For that individual, the cloned embryo would be a regenerative fountain of youth: It contains stem cells that share the individual's genetic makeup and could someday be grown into a wide variety of precisely matched tissues, including neurons to treat Parkinson's disease, or cells to mend a failing liver. The plans of closely held Advanced Cell are provoking both anger and skepticism. The disclosure comes as the Bush Administration already faces a difficult decision whether to permit government funding for studies of stem cells isolated from excess embryos created for fertility procedures. Therapeutic cloning -- an idea which until now has remained largely hypothetical -- raises new ethical concerns, partly because the cloned embryos must be created specifically for research. There is also mounting worry that embryo-cloning experiments will inevitably lead to the birth of cloned humans. Advanced Cell scientists are already trying to produce one type of embryo clone. By tricking eggs into dividing all on their own, they are creating embryos known as parthenotes, which have DNA only from the mother. Advanced Cell has made that technique work with monkey eggs, and gotten stem cells. Now it is trying with human eggs. The next step after that is nuclear transfer, where a hollowed out egg plays host to the DNA of any individual. "We haven't done nuclear transfer with human eggs," Dr. West says, "but we will soon." To make sure the current experiment doesn't go astray, Dr. West formed a board of ethical advisers. The eight-member ethics board met for the first time late last August in the Hyatt Hotel at Boston's Logan airport. According to Ronald Green, the Dartmouth University professor of religion who serves as the group's chairman, the ethics group didn't argue over whether embryo cloning was right or wrong. "We didn't spend an enormous amount of time on that. We wouldn't have been there unless we thought that the research had important benefits," Dr. Green says. Instead, the panel focused on how Advanced Cell could acquire and use human eggs in an ethical way. Eggs, or oocytes, are available from commercial brokers, but Dr. Green's group advised against purchasing on the open market. Instead, in September, Advanced Cell began running a classified ad in the Boston Globe and other area papers that read "Research Team Seeks women aged 21-35 with at least one child to donate eggs for stem cell research. Compensation for time & effort." So far, about 60 women have answered Advanced Cell's advertisement. The women have met ethics-board member Ann Kiessling, a fertility scientist at Harvard's Beth Israel Deaconess Medical Center in Boston. Dr. Kiessling says "there's no way" that Beth Israel would ever approve the Advanced Cell cloning project. Instead, she holds the interviews in her free time at a private sperm-analysis lab. Dr. Kiessling makes sure the women understand the project, telling them their eggs will be used in a process similar to that which created Dolly the sheep. To avoid an undue financial inducement that could taint the project, the pay is $4,000, far below the $20,000 sometimes paid for eggs. Advanced Cell won't reveal how many women have agreed to the process, which requires 10 to 15 injections of potent fertility drugs and then a biopsy-like procedure to remove the eggs. All the lab work is being done under constant video surveillance, a measure that Dr. Green's board insisted upon to make sure that every embryo is accounted for and none "sidelined" for a reproductive cloning experiment. Dr. West says no embryo will be allowed to develop for more than two weeks. The prospect of carbon-copy stem cells already has raised hopes for at least one seriously ill person. Dr. Kiessling says one egg donor has repeatedly begged the company to use her eggs to clone a young relative who suffers from muscular dystrophy, hoping he might be cured. So far, her request has been refused, and the company declines to say who will donate the skin cells for the experiments, noting merely that the people to be cloned are "highly educated" individuals outside the company. Dr. West worries that the experiment could become a circus: He says he has received a standing offer from network-news producers to clone a well-known TV anchor. He declined. "That wouldn't be treating the embryo with respect," he says. Dr. West sees himself as the pioneer most prepared to push the limits of this new scientific frontier. He was a founder of biotechnology company Geron Corp., in Menlo Park, Calif., where, using corporate money, he financed a clandestine quest to isolate human embryonic stem cells. Due to a congressional ban on federal funding of human-embryo research enacted in the mid-1990s, only a few scientists were willing to study the potential of stem cells from embryos. From Geron, he moved to Advanced Cell, which had been founded in 1994 by Avian Farms, a subsidiary of the Thai conglomerate Charoen Pokphand Group, to commercialize animal-cloning techniques being developed at the University of Massachusetts. (Massachusetts is one of several states that ban embryo research, but Advanced Cell says it doesn't believe its work is affected.) In 1999, Dr. West and other investors bought out the company, later raising $5 million from ATP Capital, a New York venture-capital firm specializing in agricultural technology. The company has since raised additional capital of at least $3 million from private investors and banks. Advanced Cell already had started making preliminary attempts to clone embryos. Its chief scientist, Jose Cibelli, created a living embryo by fusing one of his own cheek cells with a cow egg. However, that approach proved inefficient, and Advanced Cell moved to human eggs early last year. Arthur Caplan, a top bioethicist from the University of Pennsylvania who served as a scientific adviser to Advanced Cell, resigned from the company's science board last summer. He worried about widespread societal opposition to creating embryos specifically for research. And he says that while Advanced Cell was using his name, it wasn't seeking his advice. Advanced Cell lost another ethicist, Glenn McGee, a colleague of Dr. Caplan's at the University of Pennsylvania, soon after the ads seeking egg donors started to run. He complained that the company was using the board as a rubber stamp and was too focused on amassing patents. The experiment carries real dangers for participants. The company is refusing to release the names of women who have donated eggs and the names of the doctors it works with. Some ethics-board members wish to remain anonymous, citing the risk of attacks by antiabortion extremists. Robert Lanza, Advanced Cell's No. 3 executive and its medical director, is nervous about the repercussions of undertaking the experiment without explicit government approval. "Somebody is probably going to get shot," he says. Last winter, Advanced Cell's chief scientist, Dr. Cibelli began picking up the first of the human oocytes collected at an area clinic and driving them back to Advanced Cell, accompanied by a bodyguard. Write to Antonio Regalado at [log in to unmask] SOURCE: The Wall Street Journal http://www.wsj.com/ * * * ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn