by Steven Ertelt
February 12, 2008
Washington, DC (LifeNews.com) — Embryonic stem cell research has had troubles in animal studies with immune system rejection issues and the formation of tumors, but one leading biotech firm says it’s going to try experiments on humans this spring. The chief executive of biotech Geron said Monday that trials with embryonic stem cells await FDA approval.
Dr. Thomas Okarma said his company wants to begin work on injecting the controversial cells into humans with spinal cord injuries in a few months.
According to a CNN report, Okarma said the studies would involve 40 patients and it would be the first time the cells had been used in humans after work on injecting the cells into rats with similar problems.
Okarma said whether Geron proceeds with the experiments depends on whether the Food and Drug Administrations gives the biotech firm the green light. That could be difficult as the agency may set the bar very high over ethical concerns.
CNN quoted industry analyst Ren Benjamin as saying the process to get approval could be time-consuming because of the controversy involved.
"This is the first time that a human embryonic stem cell application is being submitted to the FDA, so there’s a good chance that some questions will arise," he said.
Two other biotech firms, Advanced Cell Technology and Novocell, want to include humans in embryonic stem cell research studies. ACT has announced plans to begin later this year while Novocell is further behind.
Another firm, Neuralstem, which uses cells obtained from babies victimized by abortion, also wants to test its methods on humans if the FDA gives it approval.
The trials pose problems other than objections from pro-life groups — who say the research is immoral because it involves the destruction of human life.
The controversial science has never been able to overcome immune system rejection issues that don’t inhibit the use of adult stem cells.
Wisconsin stem cell scientist James Thomson, who discovered embryonic stem cells, admitted embryonic stem cell research still has problems when he commented on the new direct reprogramming technique in November.
Thomson says the direct reprogramming process eliminates the problem scientists have had of using embryonic stem cells in medical transplants.
Reprogramming an individual’s own cells to mimic stem cells provides a way to create individually tailored transplant tissue unlikely to be rejected by that person’s immune system.
"These cells should be perfectly matched with the patient, so the immune system should not attack it. But most of the other challenges [associated with embryonic stem cells] are intact," he told MSNBC.
However, Okarma rejected the new method at the time of its announcement, in part because his firm spent $100 million on embryonic stem cell research.
"Most of the people who are doing this work and make the claim that this is going to change the therapeutic field really know nothing about cell therapy," Okarma claimed.