FDA Seeks Injunction Against Two Stem Cell Clinics For Alleged Marketing And Safety Violations

The FDA filed a federal lawsuit on May 9, 2018 seeking a permanent injunction against two stem cell clinics to require that they cease marketing their stem cell products until, among other things, they obtain necessary FDA approvals and correct their alleged violations of current good manufacturing practice requirements.

US Stem Cell Clinic

The FDA is seeking a permanent injunction against US Stem Cell Clinic LLC of Sunrise, Florida, and others associated with it, from marketing to patients stem cell products without FDA approval and violating current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk. The FDA seeks an order of permanent injunction requiring US Stem Cell and the individual defendants to cease marketing their stem cell products until, among other things, they obtain necessary FDA approvals and correct their violations of current good manufacturing practice requirements.

The FDA inspected US Stem Cell Clinic in April and May 2017 and reportedly found evidence of significant deviations from current good manufacturing practices in the manufacture of at least 256 lots of stem cell products by the clinic, including its alleged failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of products purporting to be sterile, which puts patients at risk for infections.

The FDA issued a warning letter to US Stem Cell Clinic in August 2017 that cited an FDA inspection that reportedly found that it was processing adipose tissue (body fat) into stromal vascular fraction (a cellular product derived from body fat) and administering the product both intravenously or directly into the spinal cord of patients to treat a variety of serious diseases or conditions, including Parkinson’s disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease and pulmonary fibrosis.

The FDA has not approved any biological products manufactured by US Stem Cell Clinic for any use.

California Stem Cell Treatment Center

The FDA seeks a permanent injunction against the second stem cell clinic, California Stem Cell Treatment Center Inc., that has multiple locations in California, and others associated with it, from marketing to patients stem cell products without FDA approval. Two of the individual defendants allegedly control the operations of approximately 100 for-profit affiliate clinics, including the California Stem Cell Treatment Center.

The FDA is seeking an order of permanent injunction requiring California Stem Cell Treatment Center Inc. and Cell Surgical Network Corporation, and the individual defendants, to cease marketing their stem cell products until, among other things, they obtain necessary FDA approvals and correct their alleged violations of current good manufacturing practice requirements.

The FDA inspected California Stem Cell Treatment Center’s Beverly Hills and Rancho Mirage facilities in July 2017 and reportedly found evidence of significant deviations from current good manufacturing practice requirements, including failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of products purporting to be sterile, which puts patients at risk for infections.

California Stem Cell Treatment Center products reportedly are also being used for the experimental treatment of patients who suffer from a variety of serious diseases or conditions, including cancer, arthritis, stroke, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), macular degeneration, Parkinson’s disease, chronic obstructive pulmonary disease (COPD) and diabetes.

The FDA has not approved any biological products manufactured by California Stem Cell Treatment Center for any use.

Source

If you or a loved one suffered harm due to stem cell therapy, you should promptly consult with a stem cell lawyer in your U.S. state who may investigate your stem cell medical malpractice claim for you and represent you in a claim against a stem cell clinic, if appropriate.

Visit our website or call us toll-free in the United State at 800-295-3959 to find stem cell lawyers in your state who may assist you.

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This entry was posted on Monday, May 28th, 2018 at 5:29 am. Both comments and pings are currently closed.

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