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F.D.A. Moves to Stop Rogue Clinics From Using Unapproved Stem Cell Therapies

F.D.A. Moves to Stop Rogue Clinics From Using Unapproved Stem Cell Therapies


The Food and Drug Administration said on Wednesday that it was seeking court orders to stop two clinics from using unapproved stem cell treatments that in some cases have seriously harmed patients.

The clinics remove fat from patients’ bellies by liposuction and then inject an extract of it into various parts of the body like knees or the spinal cord, on the theory that the extract contains stem cells that can provide replacement cells that will repair the damage from injury or illness.

The agency filed two complaints seeking permanent injunctions in federal court, one against U.S. Stem Cell Clinic L.L.C. of Sunrise, Fla.; its chief scientific officer, Kristin Comella; and its co-owner and managing officer, Theodore Gradel.

The second complaint was against the California Stem Cell Treatment Center, with locations in Rancho Mirage and Beverly Hills; the Cell Surgical Network Corporation of Rancho Mirage; and Dr. Elliot B. Lander and Dr. Mark Berman.

The U.S. Stem Cell Clinic marketed stem cell products to patients without F.D.A. approval and “while violating current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk,” the F.D.A. said in a statement.

The agency said it was acting because the U.S. Stem Cell Clinic did not address violations outlined in a warning letter from the F.D.A. last August.

Three patients lost their sight after the material extracted from fat by the U.S. Stem Cell Clinic was injected directly into their eyes in 2015 to treat macular degeneration. During an interview in 2017, Ms. Comella said the clinic did not need F.D.A. approval because it was treating patients with their own cells, which are not a drug.

In response to the F.D.A. injunction filings on Wednesday, Ms. Comella issued a statement that said, in part: “It is my life’s work to pioneer regenerative medicine and educate the public about its healing potential. I remain steadfast that no government agency should deprive individuals of their right to harness the cells that exist in their body.”

In the complaint against the California Stem Cell Treatment Center, the F.D.A. said it had acted in August to prevent the use of a “potentially dangerous and unproven treatment belonging to StemImmune Inc. in San Diego,” and given to patients at the clinics in Rancho Mirage and Beverly Hills.

In August, United States marshals, acting on behalf of the F.D.A., seized vials of smallpox vaccine that was being used to create a stem cell product that was being given to cancer patients at the California clinics. The product posed a risk to those patients of inflammation of the heart and surrounding tissues, the agency said.

The California center trains other physicians in how to extract stem cells and has affiliates around the country. A Florida woman, Doris Tyler, lost her sight after being treated at an affiliate, the Ageless Wellness Center in Peachtree City, Ga. Cells from her fat were injected into both eyes.

Dr. Berman said that many people had been helped by his clinic and that he had tried to work out a compromise with the F.D.A. but was unable to do so. He also said he believed the cells that are harvested from individuals do not constitute a drug and should not be regulated as such.

In its statement, the F.D.A. also said that both the U.S. Stem Cell Clinic and the California Stem Cell Treatment Center were using cell extracts to treat serious conditions — including Parkinson’s disease, amyotrophic lateral sclerosis and chronic obstructive pulmonary disease — but that their products were not approved for any use.

The F.D.A. oversight of stem cell therapies and regenerative medicine is still in flux. In August, Dr. Scott Gottlieb, the agency’s commissioner, called the field one of the most promising areas of science and medicine, holding great promise for some of the world’s most intractable illnesses. He vowed that the F.D.A. would ease the path to approval for researchers and companies that were developing legitimate treatments — a program authorized by Congress in the 21st Century Cures Act.

At the same time, however, Dr. Gottlieb vowed to crack down on clinics making hollow claims and marketing unsafe treatments. He also announced the action against the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills and against the U.S. Stem Cell Clinic.

In November, the F.D.A. continued work along both themes.

The agency acknowledged the difficulty in pursuing rogue clinics and suggested that consumers check up on stem cell clinics before receiving treatment.

Dr. Peter Marks, director of the F.D.A.’s center for biologics evaluation and research, said that the agency would continue to pursue unscrupulous clinics, but that those performing orthopedic procedures — injecting the fat-derived cells into joints — would take a back seat to clinics that inject or infuse cells into the central nervous system or bloodstream.

At the time, Dr. Marks said: “There are hundreds and hundreds of these clinics. We simply don’t have the bandwidth to go after all of them at once.”



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