Move over, Raelians.
Researchers in South Korea rocked the world with news in Science online that they have become the first to develop stem cells from a cloned human embryo, using somatic cell nuclear transfer.
Robert Lanza, vice president of medical and scientific development for Worcester, Mass.-based Advanced Cell Technology Inc., praised the South Koreans' work but said it should have happened here.
"We could have put this out a year ago, or so, had we the resources," Lanza told BioWorld Today. "We would be on the verge of clinical trials; we have the science worked out."
On the subject of embryonic stem cell (ESC) cloning and somatic cell nuclear transfer, there hasn't been much headline-making news since December 2002, when a fringe religious group, known as the Raelians, claimed to have cloned a human being. Raelians believe life was created in a lab by extraterrestrials, and most observers regarded the group's cloning claim as far out. The group never produced any scientific evidence to back up their announcement.
Now, Woo Suk Hwang and colleagues at Seoul National University have created 30 cloned embryos, using 242 eggs from 16 healthy women, each of the women having donated the egg and the cell from which the nucleus was taken for insertion into the egg.
About one-fourth of the treated eggs developed all the way to the blastocyst stage, making them ready for the harvesting of ESCs, but scientists were only able to glean a cell line from one of the 30 blastocysts cultured, possibly because of abnormalities in the others.
Still, the main hurdle in primate cloning was jumped: loss of division factors when the nucleus is taken from the egg. The stem cell line derived from the cloned embryo had many of the characteristics of ESCs, Science reported, including an ability to divide indefinitely. When injected into mice, they formed cell types including cartilage, muscle and bone.
Kevin Wilson, director of public policy for the American Society for Cell Biology, called the South Koreans' progress "very important," and noted the likely overreaction of laypersons who fear "there will be cloned babies tomorrow." The ASCB consists of 11,000 basic biomedical researchers in the United States and 45 other countries around the world.
What might be more worth considering, Wilson said, are the reasons why the ESC breakthrough took place overseas.
"If this research in Korea continues to go forward and is successful, what happens is that the U.S. ends up purchasing the results of research that really should have been done here," he said. Stem cell research in Singapore, Wilson told BioWorld Today, has been picking up "specifically because they saw the U.S. take a pass."
He recalled hearing a radio talk-show host remarking that embryonic stem cell research is "illegal" in the U.S., which is false, although much of the work is done below the radar.
"Nobody talks about it," he said.
The South Korean scientists were quick to point out their work is aimed at therapeutic applications, but advocates of cloning experiments in the U.S. braced for protests and possible legislative fallout.
"Already, an uncertain political climate has slowed this significant avenue of research considerably [in the U.S.]," Carl Feldbaum, president of the Washington-based Biotechnology Industry Organization, said.
"It's no coincidence that much of the groundbreaking work in this field is being done overseas," he added, citing "the will of a solid majority of Americans" to have laws that ban reproductive cloning, but encourage therapeutic research.
Advanced Cell Technology (ACT), a little over two years ago, said it had cloned a human embryo, and late last year said in a published report that it had grown a cloned embryo to at least 16 cells. (See BioWorld Today, Nov. 27, 2001.)
Lanza said there is "virtually no funding [in the U.S.]" for ESC work.
"Once upon a time, venture capitalists invested in research. Now, they want a finished product, and President Bush hasn't done much to help the situation," he said.
Whereas Lanza once compared ESC experiments to going into battle with one hand tied behind his back, he has revised the metaphor. Now, he said, both hands are tied.
"We're not the only company hurting," he added. "Many cell-therapy companies have gone under" or face hard times.
ACT did disclose earlier this month a study to be published in Circulation Research, the journal of the American Heart Association, that showed nuclear transfer cloning was used successfully in a mouse to regenerate its infarcted heart. Menlo Park, Calif.-based Geron Corp. is developing cell-based therapeutics for a variety of diseases based on differentiated cells derived from human ESCs.
All other potentially therapeutic results with cloning, though, have been overshadowed by the South Koreans' report on success with human embryos.
"It's a numbers game," Lanza said. "They had almost 250 eggs available to them, and they didn't have to pay for them," whereas ACT was able to do only a few experiments, since volunteers could not be used.
"Our ethics advisory board decided that if you did not compensate [donors], it was exploitation, and if you compensated them too much, it was commodification of women," Lanza said.
A price of $4,000 per donor was settled on, but the number was more like $25,000 after medical and psychiatric exams and other factors were included.
Ethical points of ESC research were "debated very extensively," and another rule was that each donor had to have borne one child, so that "as remote as the possibility may be, if something went wrong, at least they had a child already," Lanza said. The upshot was a limit to the field of donors, since "the vast majority are younger women, in college or whatever," he added.
News of the South Koreans' success was disclosed just before the meeting of the American Association for the Advancement of Science, which began in Seattle Thursday. Wilson said ethical concerns might continue to hobble ESC research in the U.S.
"In the next five to 10 years, the scientific community will continue to have these tough questions they are going to be asking society to answer," he said. "They are going to keep pushing the ceiling. Society, it looks like, is going to keep pushing back, [saying,] No, that's too much.' And this is not the only issue. This is just the start, biomedically."