A Johns Hopkins medical panel announced Monday that stem cells originally approved for federally funded research are not suitable to be used in future clinical trials. According to the panel, the stem-cell lines were initially grown on mouse cells. This could create problems as the cells may harbor mouse viruses that the human body would not be able to combat. The advisory panel stated that using these in human trials would be unethical and risky, especially considering safer alternatives that are available.
In Monday’s statement, Dr. Ruth Faden, panel member and executive Director of the Phoebe R. Berman Bioethics Institute at Johns Hopkins, expressed her doubts as to the safety and effectiveness of these regulations.
“Conducting a federally funded clinical trial of human ES cells, under current federal policy, would require using cell lines that none of us feel should be used in people, since it is now feasible to create safer lines,” Faden said.
However, critics point to practices, such as the use of discarded embryos from fertility clinics, as an ethical reason to place restrictions on the research.
The Working Group on Criteria for Cell-based Therapies, made up of stem-cell experts, scientists and ethicists, was formed by Johns Hopkins University in order to consider the ethical and scientific concerns involved in stem-cell research. Developing its report over 22 months, the panel expressed optimism over the developments of stem-cell research but wariness over any human trials involving the currently approved cell lines.
The federal government’s role in the funding of stem-cell research has been shaped by President Bush’s decision to allow federal funds to be used only for cell lines created prior to 9 p.m. Aug. 9, 2001.
Bush also called for a ban on all types of human cloning, including the cloning of embryos in order to acquire stem cells for research. This position has placed him at odds with scientists and researchers who point to the great strides that have been made in stem-cell research over the last two years, especially overseas, and say it is a mistake to place restrictions when there are now better ways to go about running test trials.
University of Wisconsin is one of the leading suppliers and researchers of stem cells. UW professor of anatomy and neurology Su-Chun Zhang indicated that the policy would have a negative effect on future research.
“In the short term it can be beneficial, because it allows us to use the lines. In the long term, it is a limiting factor, because we need more [lines],” Zhang said.
As a result of the government restrictions, many stem-cell researchers have turned to private funding for support. This has spurred debate over the need for federal oversight and the effectiveness of independently financed research.
UW professor Steven S. Clark indicated his agreement with the panels’ findings but expressed his support for to the need of federal cooperation.
“Certainly, stem cells are a new thing, and there are potential medical and ethical concerns. At the federal level you can have some oversight; I think it is appropriate, to prevent dangers from happening,” Clark said.
However, Clark expressed concern that while the United States has wrestled with the issue of stem-cell research, many other countries have gone ahead and made significant progress in the matter.
“We already have seen a brain drain from the United States to other countries,” Clark said. “For example, China is making a huge effort, and many Chinese scientists have left here to go home. They are doing things that are ahead [of research being done] in the United States.”