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Unregulated stem cell clinics are proliferating throughout the US. A case in point is the Cell Surgical Network (CSN), which has grown over the last two years to encompass 42 independent centers that offer to inject patients' own stem cells back into their bodies in an effort to treat any of more than 30 different diseases and injuries.
Affiliate members of the network, which now spans 22 US states, claim their therapies involve minimal manipulation of a person's own tissue—specifically, the adipose-derived stromal vascular fraction (SVF), a soup of mesenchymal stem cells and other cell populations found in fat—all isolated in a closed, sterile procedure. This surgical procedure, the CSN maintains, falls outside the regulatory authority of the US Food and Drug Administration (FDA). But Leigh Turner disagrees.
Turner, a bioethicist at the University of Minnesota in Minneapolis, wrote a letter last year to Celia Witten, director of the Office of Cellular, Tissue and Gene Therapy at the FDA's Center for Biologics Evaluation and Research, urging the agency to investigate whether the CSN (known then as the California...