Korean stem cells not for everyone

Canadians and Germans left out of Korean stem cell hub, but most of U.S. permits import

By | October 31, 2005

Scientists in countries with the most restrictive policies on research cloning may not be able to take advantage of the international consortium based in South Korea, which was hailed this month as a means to provide stem cells to researchers living in restrictive environments. Most U.S. researchers are allowed to import the lines, but researchers in Canada and Germany cannot, and some experts are voicing concerns about how the consortium will handle ethical and commercial issues.

South Korean veterinarian and stem-cell biologist Woo-Suk Hwang will head the World Stem Cell Hub, based at Seoul National University, with two satellites labs in the San Francisco area and in England, according to a New England Journal of Medicinearticle coinciding with the consortium's announcement. The researchers plan to recruit egg and somatic cell donors in all three countries and Korean technicians will travel to the satellite labs to perform somatic cell nuclear transfer (SCNT). Scientists from many countries can apply to have disease-specific cell lines created for their projects.

Most researchers in the U.S. should be able to use this resource, as long as they do not use federal money to study the cell lines, according to LeRoy Walters of Georgetown University's Kennedy Institute of Ethics. "There is only one state—South Dakota—that has a law that prohibits bringing into the state stem cells derived elsewhere that were created through destruction of human embryos," Walters told The Scientist. The Korean cell lines will also be legal in most European countries, Walters said. Italy does not permit stem cell production within its borders, but does not regulate importing cell lines from elsewhere.

Still, not all European scientists will benefit from the initiative. Germany only allows importation of cell lines derived before January 1, 2002, Walters said, which means German researchers cannot use new lines created by the hub. Other than the German deadline, "I don't know of any country that prohibits the importation of stem cells produced through nuclear transfer in principle," Walters said.

Similar restrictions exist in Canada. All Canadian human stem cell research is regulated by the Stem Cell Oversight Committee of the Canadian Institutes of Health Research, said Michael Rudnicki of the Ottawa Health Research Institute, and this committee will not allow researchers to bring in cell lines derived solely for research purposes, he said. "Because nuclear transfer is a criminal activity in Canada, we would be unable to import those cell lines," Rudnicki told The Scientist.

Canadian scientists can, however, derive stem cells from leftover embroyos from in vitro fertilization clinics, Rudnicki said, and they can import cell lines approved by President Bush in the U.S., since the embryos that gave rise to these cells were initially created for reproductive -- not research -- purposes. All of Canada's legislation on human embryonic stem cell research will be reevaluated in 2008, Rudnicki said. "I think there's probably a growing consensus that this is ready to be re-opened."

In the U.S., the biggest concerns about working with the hub involve ethics and intellectual property rights, said Arnold Kriegstein, director of the Institute for Stem Cell and Tissue Biology at the University of California, San Francisco (UCSF). Scientists at Seoul National University have approached UCSF about possibly serving as the American satellite lab, but certain issues "need to be addressed before we could participate," Kriegstein said, especially regarding oocyte donor informed consent and compensation.

According to a report in the Korean press on October 17, Korean scientists estimate that treatment drugs from human embryonic stem cells could be on the market as soon as 2015. "It's so hard to predict" whether that estimate is valid, Kriegstein said, although he pointed out that, even in the U.S., researchers are making progress in stem-cell therapies. On October 20, the FDA approved the first neural stem cell-based therapy for Phase I clinical trials in six children with Batten disease, which causes waste products to accumulate in the brain and kills most victims before they reach their teens. The therapy is derived from slightly older fetal stem cells, not embryonic stem cells.

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