Stakeholders Debate the Regulation of an Individual’s Use of His or Her Own Cells


Taking an individual’s own stem cells, treating them and injecting them into that person’s eye, wound or tumor, is that a breakthrough medical treatment or quackery?

Well, depending on who’s doing it and what they’re actually doing, it could be either.

That was at the heart of two events I attended concerning the Food and Drug Administration’s guidances on human cell, tissue and cellular and tissue-based products (HCT/Ps).

HCT/Ps are part of the new area known as regenerative medicine—replacing, engineering or regenerating human cells, tissues or organs to restore or establish normal function. The FDA’s regulation of HCT/Ps is tiered and risk-based. Those that only minimally manipulate cells or tissue, are used in a function similar to that of the original cells or tissues, are not combined with something else and don’t have a negative effect on the body are not required to go through FDA premarket review, which is a lengthy process. The FDA has issued four draft HCT/P guidances it wants to finalize.

There was an incredible range of people at these meetings: a scientist whom everyone said should have won the Nobel Prize and maybe still will; people from companies that have been in business for a long time and now are finding that, depending on how the FDA defines terms in its new guidances, they may suddenly have to put their products through a regulatory process that could take years; people from companies that readily accept that their product has to go through premarket review but object that other companies are claiming their products qualify as less risky when, in fact, they pose a harm to patients.

There were horror stories of unqualified people injecting stem cells into patients’ eyes and causing them to go blind.

And there were speakers asking, “Why would FDA regulate use of our own body's tissue?”

My article on an FDA Sept. 8 public workshop on HCT/Ps is here and the one on the FDA Sept. 12 public meeting on the four HCT/P guidances is here.

Stay on top of new developments in health law and regulation with a free trial to the Health Law Resource Center.

Learn more about Bloomberg Law and sign up for a free trial.