Rise of U.S. Clinics Offering Unapproved Stem Cell Therapies Could Affect The Future Of The Industry

A study conducted by UC Davis suggests hundreds of clinics across the U.S. are marketing stem cell therapies for conditions ranging from aging skin to spinal cord injuries without any federal approval and scientific evidence that their treatments work.

Researchers found at least 570 such clinics, which are mainly concentrated in a handful of states – including Arizona, California, Colorado, Florida, New York and Texas – but are also scattered across other states.

Paul Knoepfler, a UC Davis stem cell scientist and co-author of the paper said the proliferation of stem cell operations suggests that the global market for largely untested therapies has come home.

 “This is not just a scattered here-and-there sort of thing. This is a full industry,” said Knoepfler, a UC Davis stem cell scientist and co-author of the paper. “It’s from coast to coast, almost every state. We found chains, individual clinics, some doctors adding a la carte therapies to their practices. ... Stem cell tourism has become a local thing.”

For decades, stem cells have been of enormous interest to scientists because of their ability to regenerate endlessly and turn into various types of tissue cells. Theoretically, stem cells could be used to treat dementia, heart disease, bone loss and paralysis by restoring damaged tissue in the brain, heart or bones.

Scientists recently discovered ways to isolate stem cells from just about any tissue in the human body, and inject it back into a person after concentrating it in large doses. They hope these concentrated stem cells will cluster around damaged or diseased part of the body and boost healing.

The vast majority of the clinics, according to the study, are promoting these types of treatments. Considered relatively safe, these therapies are sometimes not regulated by the FDA, which means clinics do not need approval before offering these types of treatments.

Scientists worry that the mushrooming of fraudulent clinics could ruin the industry as a whole. Dr. Arnold Kriegstein, head of UCSF’s stem cell program believes patients may abandon a promising field of medicine if they start having nasty side effects, start or losing faith that stem cells can enhance their health.

The U.S. Food and Drug Administration has taken various measures against specific businesses. Last year, the FDA sent a warning letter to a chain of clinics operating in California, Florida and New York. These clinics unlawfully use stem cells from individual’s fat tissue to treat conditions such as Parkinson's, autism, multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS).

A draft guideline on the use of stem cells was issued by the FDA. A public hearing is scheduled for later this year.

The study was published in the journal Cell Stem Cell.