Pusher of unproven stem cell therapies dies while awaiting verdict in FDA lawsuit

For years, California cosmetic surgeon Mark Berman was a leader of that corner of the health care world pushing unproven and unapproved stem cell treatments for a host of medical conditions.

Berman aired his claims for what he called “magic cells” in a book, video appearances and through a network of affiliated clinics around the country. Those claims caught the attention of the Food and Drug Administration, which has been trying to stamp out clinics claiming that stem cell injections can treat diseases and conditions such as Alzheimer’s, Parkinson’s, autism and even — most recently — COVID-19.

A 2018 lawsuit the FDA filed against Berman, his professional partner urologist Elliot Lander and their two stem cell businesses is awaiting a verdict from U.S. District Judge Jesus Bernal in Riverside. Whichever way it goes, Bernal’s ruling would set the stage for the next phase of the FDA’s campaign against stem cell clinics — either endorsing its position that the injection procedure amounts to administering illegal drugs or erecting an obstacle to enforcement of its rules.

Berman died April 19, according to his office. His death hasn’t been publicly announced. An email sent last week to a patient and signed by an office manager at Cell Surgical Network, which Berman co-founded with Lander in 2012, stated that he died after being hospitalized in early January.

Lander said by email, “The family will release all pertinent information in an obituary which has not been completed and published yet.” Berman’s son, Sean, confirmed that an obituary is being written.

Berman’s death provides an opportunity to review the FDA’s campaign against clinics purveying bogus stem cell treatments.

The agency’s targets are clinics that rely on a method similar to the one promoted by Berman and his colleagues at clinics branded as the California Stem Cell Treatment Center in Rancho Mirage and Beverly Hills and at scores of clinics affiliated with the Cell Surgical Network. The treatment centers were co-founded by Berman and Lander in 2010.

The method starts with extracting fat from a customer via liposuction. The fat is then refined to isolate what is known as the “stromal vascular fraction,” or SVF, which Berman asserted is rich in stem cells. The SVF is then reinjected into the customer.

Customers of more than 1,000 clinics around the country, some of which are affiliated with the Cell Surgical Network, have been charged as much as several thousand dollars for such procedures, which are seldom, if ever, covered by health insurance.

More recently, Berman, Lander and other stem cell promoters have been implying that stem cells can be used to treat COVID-19.

The FDA’s position on these claims is crystal clear. The agency observes that there is no scientifically validated evidence for those treatment claims. The agency has warned prospective customers to stay away from the claims’ promoters.

Sean Berman, Berman’s son, who says he is a consultant to Florida stem cell company American Cell Technology, said that as far as he is aware, no patients have been treated for COVID-19 according to the protocol the FDA mentioned.

Details about Berman’s death have not been made public.

A person who answered the phone at California Stem Cell Treatment Center said Berman died of “complications from COVID.”