Doctors, patients pressure FDA to regulate commercial stem cell clinics

MADISON, WI - MARCH 10: Kejin Hu, research associate, looks at a colony of human embryonic stem cells under a microscope at Wisconsin National Primate Research Center at University Wisconsin-Madison March 10, 2009 in Madison, Wisconsin. On March 9, 2009 President Barack Obama signed an order reversing the Bush administration's limits on human embryonic stem cell research. Scientists at the University Wisconsin-Madison, who were the first to experiment in finding cures to neurological and muscular diseases through stem cell research, are now hoping to receive federal funding to aid in their work. (Photo by Darren Hauck/Getty Images)

The Food and Drug Administration is holding a public hearing this week on the proposed regulation of for-profit stem cell therapy clinics.

As reported in STAT, the two-day hearings will end on Tuesday, and patients, doctors and stem cell researchers have been weighing in on the ethics of commercial clinics without regulations. Supporters of the proposal argue that stem cell research hasn’t crossed the threshold into for-profit treatment, while clinics claim scientific breakthroughs in the field have benefited their patients.

But the biggest argument for FDA regulations has been about false hope that may be placed on desperate patients suffering from conditions including paralysis, erectile dysfunction and autism. Opponents of the regulation worry that the proposal may be another obstacle to the advancement of stem cell technology and research.

What do you think of the FDA’s proposal? Does it protect patients or hinder the progress of stem cell research?

Guests:

Dr. Mark Berman, MD, FACS, co-medical director of the Cell Surgical Network, a chain of clinics specializing in adult stem cell regenerative medicine.

Lawrence Goldstein, Ph. D., director of the Sanford Stem Cell Clinical Center, UC San Diego School of Medicine