Many of these clinics generally use cells derived from a patient’s own fat, and since the FDA considers those cells only “minimally manipulated,” the agency has not regulated the treatments, according to the article.
However, increasing safety concerns have prompted the FDA to propose changes. The agency is now proposing to regulate the cells as drugs. This means the clinics would be subjected to a costly and rigorous approval process before treating patients, reports STAT.
Those opposing these clinics are imploring the FDA to impose stricter regulators, while many clinic managers argue they are practicing medicine and the agency doesn’t need to give approval. Clinic operators claim their treatments are “patient-funded research,” and the prices are miniscule compared to the potential benefits.
The FDA will host a critical public hearing on the issue Monday and Tuesday in Bethesda, Md. The hearing is expected to draw testimony from nearly 100 stem cell clinics, physicians, researchers and organizations, according to California Healthline.
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