Geron Corp., of Menlo Park, Calif., announced today that the Food and Drug Administration has approved their study of a stem-cell based treatment for spinal cord injuries. Geron will be able to test the stem cell therapy in up to 10 patients who are within 14 days of a spinal cord injury leaving them paraplegic, able to use their arms but not their legs. Study participants will receive one injection within 14 days of their injury and will then be monitored for one year afterward.
Geron and the FDA both state that that the approval for the study coming on Obama's second day in office is a coincidence this approval seems an obvious signal of a sea change in the US government's position on stem cell research. George W. Bush had imposed such strict limits on embryonic stem cell research that this promising branch of medical therapeutics was practically stifled. The Obama administration seems to be cautiously reversing these limits as promised in the campaign. Cautious being an operative word. On Jan. 18 on CNN, Obama said "I like the idea of the American people's representatives expressing their views on an issue like this."
It was the dream of Christopher Reeve, and his wife Dana that advances in stem cell research could allow paralyzed victims of injury to regain their mobility. Their foundation, The Christopher and Dana Reeve Foundation has championed stem cell research, however, the Bush administration had hampered the ability for companies and universities to use stem cells due to strict limits imposed by George W. Bush and Congress. Although there certainly are moral and ethical considerations revolving around the use embryonic stem cells, the fact is that there are embryos which remain frozen after the process of in vitro fertilization. As a parent, many feel that they would gladly donate these to allow medical science to potentially save lives and help the paralyzed walk again.
The FDA has been reviewing the application for the Geron study for almost a year. It will be the first US study to use embryonic stem cells. The focus of the study is on differentiating stem cells roles in regenerating the spinal cord. Other studies using adult stem cells have shown great promise in the treatment of diseases such as Crohn's Disease and Graft Vs. Host disease. What is exciting about embryonic stem cells is that they can evolve into any cell in the body.
