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Three associated centers in California, New York, and Florida are cited for not following proper sterilization and validation procedures and for not having the appropriate licenses to manufacture a biological drug product.
Three stem-cell clinics across the United States received a warning from FDA on Dec. 30, 2015 for what the agency determined to be significant deviations from current good manufacturing practice (cGMP) and current good tissue practice (cGTP). The clinics, including the Irvine Stem Cell Treatment Center in Newport Beach, California; the Manhattan Regenerative Medicine Medical Group in New York, New York; and the Miami Stem Cell Center in Miami, Florida were found to be unlawfully producing stromal vascular fraction (SVF) stem-cell products from adipose tissue. The treatments were being prepared at the facility and administered for a variety of diseases, including Parkinson’s disease, cerebral palsy, pulmonary fibrosis, chronic obstructive pulmonary disease, multiple sclerosis, and amyotrophic lateral sclerosis. The treatments were administered intravenously, via intrathecal spinal injections, or by an oral or nasal nebulizer.
Because the fat cells were not used in a homologous manner, (i.e., to cover, connect, or cushion), FDA determined that the SVF was unlawfully being used as a biologic drug, without the proper licenses and in the absence of an investigational new drug (IND) application. Additionally, the processing of the tissue at the facilities was found to not meet required criteria, such as taking suitable measures (such as the validation of all aseptic and sterilization processes) to prevent microbiological contamination of drugs purported to be sterile.
Specifically, the workers at these facilities were found to be working in unvalidated areas without using sterile gowns or sanitized gloves. Workers not involved in the manufacturing process were allowed to enter and exit the manufacturing area, which could introduce contaminants. FDA found there were no quality control steps in place, and in general, the practices in the laboratories were “scientifically unsound.” Processing steps were not adequately documented, items in contact with the drug product (such as containers and closures) were not tested, machines were not calibrated, environmental conditions were not monitored, and products were not properly labeled with required messages, such as “For autologous use only” and “Not evaluated for infectious substances.”
Although the medical group closed its New York facility as of October 15, 2015, and provided a response to FDA with its intended corrective actions-including a disclaimer it added to its websites, claiming the group does not “utilize the addition of chemicals or enzymes to produce the SVF” and remains “consistent with all FDA Guidance relating to stem cell therapy”-FDA concluded the responses and actions were not supported by the appropriate documentation and did not prove that the procedures conducted at the facilities should be considered merely “minimal manipulations,” as the clinics attest. The clinics have 15 days following receipt of the warning letter to establish corrective actions and avoid seizure and/or injunction by the regulatory agency.