FDA seeks to shut down stem cell clinics offering unapproved treatments: 5 insights

Biologics

The U.S. Department of Justice filed lawsuits to shut down stem cell clinics in Florida and California that marketed unapproved stem cell treatments, the Los Angeles Times reports.

Here are five things to know.

1. The lawsuits were filed on behalf of the FDA, which is cracking down on unlicensed drugs.

2. The California lawsuit named the California Stem Cell Treatment Center in Rancho Mirage and Beverly Hills and its proprietors, cosmetic surgeon Mark Berman, MD, and urologist Elliot Lander, MD, as defendants.

3. According to the lawsuit, Drs. Lander and Berman have about 100 affiliated licensees nationwide, which have treated 6,000-plus patients. None of the stem cell treatments are FDA-approved.

4. In August 2017, the FDA seized nearly 500 doses of a smallpox vaccine that was going be combined with adipose-derived stem cells and administered to patients at the Beverly Hills and Rancho Mirage clinics.

5. The Florida lawsuit was filed in federal court in Miami. It named Sunrise, Fla.-based U.S. Stem Cell Clinic and its chief officers Kristin Comella, PhD, and Theodore Gradel as defendants. In August 2017, FDA agency inspectors cited it for 14 "significant objectionable conditions" at the clinic. Up to four patients treated with stem cell injections for macular degeneration suffered serious side effects, including blindness.

More articles on biologics:

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Dr. Alexandre Scheer is New York City Stem Cell Institute's medical director: 3 highlights

Global spine biologics market to hit $2.7B by 2023: 3 observations

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