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Complaint filed against two stem cell clinics by FDA in Federal Court

FDA requires the stem cell treatments to be studied under an Investigational New Drug (IND) application and has discretion to approve and give a go ahead only on the basis of how the product is manufactured to ensure appropriate steps are being taken to assure the product’s safety, purity, and strength. If a particular stem cell product is not approved by FDA and is used then FDA has discretion to take legal action. On 9th May 2018, FDA had filed complaint against two stem cell clinics in federal court that would prevent two stem cell clinics from marketing stem cell products prior to receiving FDA approval. This action signifies FDA’s willingness to take legal action against stem cell clinics that do not take FDA’s warning seriously.

FDA filed a complaint against a stem cell clinic located in Sunrise, Florida, its Chief Scientific Officer, and its co-owner and managing officer alleging that the stem cell products were marketed without FDA approval and violated current good manufacturing practice requirements. The complaint was filed when the clinic did not address the violations outlined in an August 2017 Warning Letter (OBPO 1 17-02) which was released on account of GMP violations. Some of the citations of the warning letter include- marketing stem cell products without FDA approval, processing adipose tissue 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 certain diseases or conditions, including Parkinson’s disease, chronic obstructive pulmonary disease (COPD), and heart disease, among others. The company has been asked to permanently cease marketing stem cell products until the required FDA approvals are obtained and their violations of current good manufacturing practice requirements are corrected.

FDA also filed complaint against a stem cell treatment center operating stem cell clinics in Rancho Mirage and Beverly Hills, California and two of the company's proprietors leading to permanent cease in marketing stem cell products. The cease will be there until the required FDA approvals are obtained and their violations of current good manufacturing practice requirements are corrected. The complaint was filed to prevent the use of a potentially dangerous treatment administered through intravenous injections directly into the tumors of cancer patients. The treatment center products are also being used for experimental treatments for individuals who have a number of serious diseases or conditions, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), among others although FDA has not approved any biological products manufactured by the treatment center for any use. Certain other violations including the evidence of significant deviations from current good manufacturing practice requirements were also observed. According to FDA Commissioner Scott Gottlieb, "Move to Federal court was made on account of the two clinics disregarding the law and compromising patient safety".