Regulating Stem Cell Research – Different Perspectives

With around a dozen of stem cell clinics around the United States and the wide diversity of areas in which the research is being done, standardizing regulations on the research is a hefty task. As the cell-based products like stem cell treatments are individualized and manipulated to different degrees of usage in individuals, this adds an inch of difficulty in regulations as it moves us a long step away from standardization. FDA is finding extreme difficulty in curbing the proliferating use of unproven stem cell treatment. Such treatments are preyed upon by unconscientious doctors and scientists. At the same time, this branch holds legitimate promise in saving lives which is yet to bloom.

While every effort is being done by FDA to regulate the use of stem cell treatments, a non-profit based organization of medical doctors and scientists, the International Society for Stem Cell Research (ISSCR) is working towards creating awareness and is acting as a myth buster for clinically unproven treatments.

The diversity of usage, extensive research and the amount of money put together in the area altogether form a nightmare for FDA’s regulation policies. There’s another viewpoint that presents regulation as manufacturing standards and speak against it. It seems like FDA is trying to form a law that takes into account every possibility of abuse that could happen.

Regulation in other fields such as fertility clinics are also being compared to stem cell research. Unlike the fertility clinics in places like the U.K., IVF clinics lack national regulation in the U.S. This means the government does not interfere or regulate the way the embryos are cultured or with their placement in females. FDA doesn’t have regulations when it comes to heart transplants.

FDA’s lawsuit against Regenerative Sciences is also being criticized on the above mentioned basis. Regenerative Sciences is a medical company that developed a stem cell treatment for orthopedic injuries. The company is being regulated on the grounds of not following good manufacturing practices. Comparing individualized and customized stem cell therapy with manufacturing is termed as demeaning and fret upon. With this lawsuit, FDA is also trying to categorize non-embryonic stem cells as drugs.

FDA’s action on stem cell research is being related to how gene therapy was stalled by FDA’s interference. It is said that the concerns like the Science is moving too quickly made the FDA shut down all the trials. FDA’s decision is being criticized and the example of bone marrow transplant is being cited in this reference. It is a medical procedure that is largely unregulated and is flourishing. The fact that stem cell treatments are similar to bone marrow transplant says a lot about it.

Stem cell research has a long away ahead of it. It is a very edgy science and contains a lot of hope in it.