One Stem Cell Clinic Shut Down, Another Gets Warning Letter In FDA Crackdown

Federal regulators recently took actions against two stem cell clinics that were marketing treatments for serious illnesses, seizing vaccines at one clinic and issuing a warning letter to another clinic. 

According to a press release issued by the FDA on August 28, federal officials raided California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California, on August 25. The agency seized vials of a rare vaccinia virus vaccine, which was being used to create a stem cell treatment advertised to cancer patients.

Vaccinia vaccine is used for people at high risk of contracting smallpox, such as military personnel who serve in third world countries. The vaccine is not commercially available and the FDA is concerned as to where the company received the vaccine.

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U.S. Marshals seized five vials, each contained 100 doses of the vaccine. One vial was partially used.

The FDA indicates the clinic was using the vaccine, manufactured by StemImmune Inc., to create an unapproved and dangerous cancer treatments. The product combines the vaccine with fat tissue stem cells. Clinic staff then inject the product directly into a patient’s tumor.

Federal officials were especially concerned, as this type of treatment could cause patients with compromised immune systems to experience myocarditis and pericarditis, inflammation and swelling of the heart and tissue surrounding the heart.

“The FDA will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work,” wrote FDA Commissioner Scott Gottliebe.

Stem Cell Clinic Receives Warning letter 

On August 28, the FDA also issued a warning letter to US Stem Cell Clinic located in Sunrise, Florida.

The FDA warning indicates the clinic makes stem cell products without FDA approval. In addition to the lack of approval, the clinic is also manufacturing the products in a non-sterile way that may cause patients to contract and infection.

During a recent inspection, the agency found the clinic injected stem cells derived from body fat directly into the spinal cord of patients. The clinic claims the stem cells treat serious diseases, including Parkinson’s disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease, and pulmonary fibrosis.

The FDA has not approved or reviewed products manufactured by US Stem Cell Clinic for any use. Additionally, the FDA has not approved any stem cell based treatments or products, other than cord blood-derived cells.

During an inspection of the clinic, the FDA found evidence the clinic deviated from “good manufacturing practices” of 256 lots of stem cell products. They also failed to follow certain procedures meant to prevent contamination of the products to make the products sterile, putting patients at risk of infection.

Additionally, the agency claims the clinic attempted to impede the FDA investigation by refusing entry to health officials for the inspection. The clinic also allegedly denied FDA investigators access to clinic employees.

The FDA requested a written response within 15 days from the clinic as to how they plan to correct the problems. Failure to comply could result in seizure, injunction, or prosecution.

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