On Aug. 9, President Bush announced federal money may be used to study embryonic stem cell lines derived from embryos left over at fertility clinics. Only existing embryonic stem cell lines will be eligible for federal funding under the president's policy.
There are 64 lines held by institutions around the world that would be acceptable under the president's decision. These lines were made by researchers by taking cells from various parts of newly developing embryos, or some say pre-embryos, within days of fertilization. This usually means less than five days after fertilization. These cells have been said to be able to regenerate themselves indefinitely.
Are 64 lines enough and could they be used for treatment of Parkinson's or Alzheimer's diseases? Are they viable and will they be readily available? These are just a few important questions that have been raised by researchers.
The number of 64 stem cell lines may be an overestimate of the actual number useful for research without regard to therapeutic suitability. Some of the lines are so young and fragile, according to the Washington Post, that they may never prove useful scientifically. Sixteen of the lines held by Swedish scientists at Goteborg University, Goteborg, Sweden, have been studied so little that it is unclear whether they are capable of becoming any kind of human tissues.
Health and Human Services Secretary Tommy Thompson was quoted as saying these lines "are diverse, robust and viable for research."
H. Peter Erickson, a neurobiologist at Goteborg, has said that only three of the 19 lines could be called stem cell lines. He concedes that there may have been misinterpretation as to the definition of a "stem cell line."
Even if there are a number of useful lines, how many will be available to scientists for study? Presently CyThera Inc., of San Diego, plans to make one colony or cell line available to researchers within the next several months. They said they wanted to provide only the highest quality tools possible. Ironically, this is a 12-person biotechnology firm. They have a big job.
The potential for selling stem cell lines and their associated technologies might affect the availability of these lines. Academic scientists have already become concerned about the patent rights to five of the lines created at the University of Wisconsin and funded by Geron Corp. Geron is embroiled in a federal lawsuit with its funding partner, Wisconsin Alumni Research Foundation, concerning the rights to other uses of stem cell technology. In addition, other scientists fear that Geron has a stranglehold on patent rights that will slow down research that might lead to treatments for diseases such as diabetes and Parkinson's. It is unclear whether anyone will actually make money selling these lines, but the controversy over availability and selling such cell lines and restricting their use are matters for industry, science, medicine, the public and now the legal system to decide.
Settling these issues are crucial for scientists to obtain the high quality research materials and federal funding needed to determine whether embryonic stem cells can be used to replace damaged and diseased tissues and organs. However, the next problem will be the issue of whether these cell lines are safe enough to be used to treat patients. How these cell lines were derived and grown could dramatically affect whether the Food and Drug Administration will allow them for human use.
This is a subject for a future column.
Catherine Phillips Ph.D., is professor of internal medicine and assistant dean for research at Texas Tech School of Medicine and research and development coordinator for Amarillo Department of Veterans Affairs Health Care System.