Feds Crack Down on Rogue Stem Cell Clinics; California Remains Unhurried

Expensive treatments are harming patients

Peddling unproven treatments has a long history. The latest involves stem cells.

The long-running stories of rogue stem cell clinics and their dubious and sometimes dangerous treatments entered a new chapter this month with stepped-up action by the federal government. 

In California, however, lawmakers are ignoring the matter entirely, and the State Medical Board had nothing new to say this week on overdue efforts to rein in the treatments. 

The Golden State has the largest number of these clinics, which have been dubbed “snake oil” enterprises by the chairman of the California stem cell agency, Jonathan Thomas. The most recent estimate for their numbers nationally is about 1,000 with the majority in California.

Earlier this week, the state stem cell agency carried an article on its blog, The Stem Cellar, that was headlined, “Watch out for predatory stem cell clinics.” The matter also drew attention from UC Davis stem cell scientist Paul Knoepfler who wrote about a Utah clinic that received a warning letter from the Food and Drug Administration (FDA) that cited failures involving contamination and the spread of communicable disease. 

The item on the blog of the California Institute for Regenerative Medicine (CIRM), as the stem cell agency is officially known, cited two reports this month on unregulated clinics. 

Kevin McCormack, senior director of CIRM communications, wrote,  

“The first was from the Pew Charitable Trusts entitled: ‘Harms Linked to Unapproved Stem Cell Interventions Highlight Need for Greater FDA Enforcement’ with a subtitle: ‘Unproven regenerative medical products have led to infections, disabilities, and deaths.’”

McCormack continued,

“The Pew report cites the case of one California-based stem cell company that sold products manufactured without proper safety measures, ‘including a failure to properly screen for communicable diseases such as HIV and hepatitis B and C.’ Those products led to at least 13 people being hospitalized due to serious bacterial infection in Texas, Arizona, Kansas, and Florida.

“Shocking as these statistics are, the report says this is probably a gross under count of actual harm caused by the bogus clinics. It says the clinics themselves rarely report adverse events and many patients don’t report them either, unless they are so serious that they require medical intervention.”

The Pew study came as the FDA began a long-awaited crackdown on the clinics, a move that is attracting little attention in the mainstream media despite reports of the treatments causing blindness, hospitalizations and tumors. 

In California, moreover, a check of state legislation today turned up no efforts aimed at bringing the clinics under control. Responding to a question from the California Stem Cell Report, the State Medical Board said this week, “The Board has no update to share about this particular subject at this time.” 

The board began its inquiry into the rogue clinics in 2018 but has shown little progress. And legislation targeting the clinics died a virtually silent death in Sacramento in 2019. 

While the clinics offer unproven treatments that, according to regulators, can harm patients, a price is also being paid in terms of the credibility of legitimate stem cell research, including the studies financed by the state’s $12 billion stem cell agency. The clinics and their claims are what stand out in many persons’ minds. 

(In a comment posted following this article, stem cell scientist Jeanne Loring says that the success of CIRM and other stem cell research has enabled the rogue clinics to piggyback their marketing efforts on those achievements.)

Over the years, when this writer is asked about stem cell research by folks from the general public, the questions are almost always framed in the context of the bogus claims of the unregulated clinics. Their marketing is shaping much of the public opinion about stem cell research, legitimate and otherwise. 

Indeed, during the last few months as editor of the California Stem Cell Report I have fielded an increasing number of questions from readers and others about whether they should pay many thousands of dollars for this or that sort of treatment -- none of which involves legitimate research enterprises or proven therapies.

The website of the California Medical Board says its mission is to “protect health care consumers.” Lawmakers as well have a responsibility to do the same. It is past time for them to step up.