Stem Cell Clinics Sued by FDA for Unapproved Treatments

By Christopher Coble, Esq. on May 11, 2018 | Last updated on March 21, 2019

According to some, the potential for stem cell therapy to treat chronic diseases and serious medical conditions is limitless. According to California Stem Cell Treatment Center, its stem cell products could treat cancer, arthritis, stroke, amyotrophic lateral sclerosis, multiple sclerosis, macular degeneration, Parkinson's disease, chronic obstructive pulmonary disease, and diabetes, just to name a few.

And, according to the Food and Drug Administration, California Stem Cell Treatment Center ("CSCTC") never got approval that those treatments were either safe or effective. So the FDA is now suing California Stem Cell and another clinic in Florida in an effort to block them from marketing unproven treatments to thousands of patients. You can see the California lawsuit below.

No Miracle Cure

According to the lawsuit, filed by the U.S. Department of Justice, "patients pay thousands of dollars to receive a single CSCTC product, and some patients pay much more to receive multiple treatments." What did those patients get for their money? According to a recent FDA inspecting of CSCTC's clinics in Rancho Mirage and Beverly Hills, a lot of adverse reactions.

One patient had stem cell treatment in her knee and was unable to walk for six months afterward. Another lost consciousness and was hospitalized after being treated. One needed to be hospitalized with an infection after receiving injections into the brain via catheter, and another "reported two retinal detachments after receiving ... injections in her eyes."

State of Stem Cell Marketing

The government claims, "There have been no adequate and well-controlled studies performed on the CSCTC products demonstrating that they are safe or effective for any indication." Therefore, the lawsuit is asking a federal court in California to shut down the clinic and its doctors from further stem cell treatments.

A separate complaint was also filed in a Florida federal court claiming U.S. Stem Cell Clinic also marketed stem cell treatments to patients without FDA approval and additionally manufactured its products in ways that put patients at risk. You can read the full California complaint here:

Stem Cell Therapy Complaint by FindLaw on Scribd

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