FDA warns San Diego stem cell clinic over treatment

In another strike against the for-profit stem cell industry that has blown up around the country in recent years, federal authorities on Tuesday issued a formal warning to a San Diego clinic that uses fat-derived cells to treat a wide variety of conditions, from multiple sclerosis to Parkinson’s and Alzheimer’s disease.

StemGenex Inc. already is being sued by former patients who allege the company made false claims about its successes and patient satisfaction rates.

The U.S. Food and Drug Administration has ramped up efforts to rein in for-profit stem cell clinics in recent months, partly in response to complaints from scientists and consumers after several patients experienced serious complications — including blindness — related to stem cell treatments.

StemGenex has not been connected with any major complications made public. But in the warning letter from the FDA, which was sent to StemGenex on Oct. 31, the agency cites “multiple complaints involving possible adverse events” from the company’s stem cell product.

In a statement released Tuesday, FDA Commissioner Scott Gottlieb said that though stem cell medicine remains a source of great potential for health benefits, “we continue to see bad actors exploit the scientific promise of this field to mislead vulnerable patients into believing they’re being given safe, effective treatments.”

He added, “These stem cell producers are leveraging the field’s hype to push unapproved, unproven, illegal, and potentially unsafe products.

This is putting patients’ health at risk.”

StemGenex officials did not respond to requests by email and by phone for comment.

The warning letter, which was announced by the FDA on Tuesday, states that the company has two weeks to address the concerns raised by the agency. The warning alleges that StemGenex is marketing products without appropriate FDA oversight. It also cites several quality control problems with the company’s manufacturing processes.

Several hundred forprofit stem cell clinics have appeared across the country over the past five or so years. Almost all of them sell therapies — typically at a cost of $5,000 to $20,000 per treatment — that are not approved by the FDA, and many of which are specifically forbidden by federal regulations. The treatments are not proven to be safe or effective by normal scientific standards and have not been tested in animal or human studies.

For years a handful of critics have asked the FDA to stop these clinics from selling unproven therapies, but the agency only recently has targeted the operations with warning letters and other actions. Earlier this year, the FDA took its most aggressive action to date, requesting permanent injunctions to stop two major forprofit providers — Cell Surgical Network in Beverly Hills and U.S. Stem Cell Clinic in Florida —from marketing stem cell therapies.

Both companies are challenging the injunctions, and their cases have not been resolved.

StemGenex uses a product that takes fat from a patient, strips out and cleanses the stem cells found in that fat, then delivers the stem cells back into the individual by injection or other means. The product is similar to one used by Cell Surgical Network, U.S. Stem Cell and many other forprofit clinics.

The clinics claim that the fat stem cells can treat a wide variety of health problems by performing different biological functions, including replacing damaged cells throughout the body and improving immune function. Scientists who study stem cells say it’s impossible that fat stem cells could do all that.

UC Davis scientist Paul Knoepfler, who has been a constant critic of the for-profit stem cell industry for years, said he was pleased to see a new warning letter issued.

“But there are probably hundreds of other clinics using these unapproved drugs,” he said. “U.S. Stem Cell, Cell Surgical Network, StemGenex — those are just three of the highest profile places.”

Leigh Turner, a bioethicist at the University of Minnesota who also has raised concerns about the for-profit industry, said he, too, was glad to see some action from the FDA. But he noted that he had sent letters to the FDA suggesting the agency look into StemGenex more than five years ago. He wondered why it has taken so long to issue a warning.

“Had the FDA acted five or six years ago, there would have been a whole bunch of individuals who wouldn’t have gone to this business and might not have spent hundreds of thousands of dollars,” Turner said. “Regulatory inaction has consequences. There are costs and losses with the FDA taking too long to show up on scene.” Erin Allday is a San Francisco Chronicle staff writer. Email: eallday@ sfchronicle.com Twitter: @erinallday