FDA Ruling on Stem Cells
The US District Court has ruled in favor of the FDA who claimed that the use of a patient’s own stem cells to regulate therapy should be subject to the same regulations as drug therapies.
A company called Regenerative Sciences takes stem cells from bone marrow, processes them, and injects them back into the patient in order to treat joint pain. However, the FDA called this procedure “unapproved biological drug product manufacturing” in 2010 and ordered the prevention of the treatment.
The FDA also found that the company was sacrificing patient safety due to flaws in cell processing, and the procedure includes potential transmission of communicable diseases. Regenerative Sciences’ response was that cells were not significantly changed before reinjection so it was simply routine medical practice, and proceeded to continue the procedure in a Cayman Island clinic. The concern now is that more non-FDA approved procedures will take place outside the US, such as Mexico, as a method to avoid FDA regulation.
Stem cell therapy has the potential to be an incredibly powerful tool in treating a wide range of diseases and therefore is a topic about which there is a lot of interest and excitement about its potential applications. The regulation of stem cell therapies is necessary to protect patients from being exploited by unethical practices.