Embryonic Stem Cell Trials Approved

Special Report - August 4, 2010
The Food and Drug Administration (FDA) has approved the first tests on humans of a therapy derived from embryonic stem cells, which are harvested from human embryos. The Geron Corporation and the University of California, Irvine developed the new therapy to treat spinal cord injuries and restore some movement or sensation by repairing the myelin insulation around nerve cells in order to restore “the ability of some nerves to carry signals.” The FDA initially approved the therapy for clinical trial on humans in January 2009, but suspended that approval when some injected rats developed cysts. According to the Associated Press, “Geron had to do another study and develop better ways to check cell purity.” The Phase 1 study, which will include up to 10 patients, aims to test the safety of the therapy, and could start in the next few months, pending approval by the ethical review boards at the seven proposed trial sites, which are not being shared with the public out of privacy concerns. Additional years of testing will be required before the therapy could be approved for widespread use. A primary safety concern stems from the possibility that “any embryonic stem cells left in the mixture that is injected into the patients … could possibly form tumors,” which has been a common problem in therapies developed from embryonic stem cells.

Advanced Cell Technology is also seeking FDA approval for an embryonic stem cell therapy to treat Stargardt disease, which causes severe vision loss. However, as the Associated Press noted, “For all the emotional debate that began about a decade ago on allowing the use of embryonic stem cells, it’s adult stem cells that are in human testing today. An extensive review of stem cell projects and interviews with two dozen experts reveal a wide range of potential treatments.” Adult stem cells do not necessitate the creation and subsequent destruction of human life like embryonic stem cells. Rather, adult stem cells can be procured from non-controversial sources including umbilical cord blood and bone marrow. The article continued, “Apart from these efforts, transplants of adult stem cells have become a standard lifesaving therapy for perhaps hundreds of thousands of people with leukemia, lymphoma and other blood diseases.” As noted in many of our previous stories, adult stem cells are already being used to treat over 70 diseases including multiple sclerosis, heart damage, juvenile diabetes, and certain causes of blindness.

Shortly after his inauguration, President Obama lifted President George W. Bush’s limitations on federal funding for embryonic stem cell research and his administration has been approving more and new lines to receive federal funding for research. Stem cell research, generally, operates under the idea that stem cells are able to turn into other types of cells.

In May 2010, North Carolina Family Policy Council president, Bill Brooks, interviewed David Prentice, Ph.D., senior fellow for life sciences at the Family Research Council, about the benefits of adult stem cells on the Council’s weekly radio program, Family Policy Matters. “Well, the benefits are several fold. Number one, you've got no moral problem with using adult stem cells. It can be the patient's own cells in many cases,” noted Dr. Prentice. “In which case, of course, you didn't have to destroy the stem cell donor to get them. But by using the patient's own adult stem cells, you also don't have to worry about any kind of transplant rejection. It's the patient's own cells, so they're not going to reject them.” The show “Understanding Adult Stem Cells,” which aired May 22, is available here for download (scroll down to the May 22 program).

Related articles:
Feds Expand Embryo Destructive Research - December 9, 2009
Clones Without Cloning - July 27, 2009
NIH Expands Embryonic Stem Cell Research - July 8, 2009
President Okays Embryonic Stem Cell Research - March 10, 2009
Another Breakthrough in Adult Stem Cell Research - October 23, 2008
Adult Stem Cells Yield More Promise - September 12, 2008
New Adult Stem Cell Source Discovered - September 7, 2007
Researcher Discovers Ethical Stem Cell Alternative - July 20, 2007
Duke Study Fuels Stem Cell Debate - June 28, 2007
Adult vs. Embryonic Stem Cell Research - FNC - March 2007
An Ethical Alternative - FNC - March 2007
Scientists Uncover New Non-Embryonic Stem Cell Method - January 9, 2007
Scientists Discover New Stem Cell Methods - August 23, 2005
The Alternative to Embryos: Successes of Non-Embryonic Stem Cell Treatments - January 2005

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