The International Society for Cell & Gene Therapy (ISCT) has slammed the decision of a federal judge in California who ruled surgical procedure using a patients’ stem cells does not fall under the FDA’s regulatory jurisdiction.

In 2017, the US Food and Drug Administration (FDA) took a series of actions “to remove unproven, potentially harmful treatment used in ‘stem cell’ centers targeting vulnerable patients.” This included the issuing of Form 483s and warning letters, the seizing of vials of materials used to create unapproved stem cell products, and the threat of legal action to “unscrupulous clinics.”

One such alleged clinic was the California Stem Cell Treatment Center (CSCTC)/Cell Surgical Network Corporation, which marketed an unapproved stem cell product consisting of excess amounts of vaccine and stromal vascular fraction (SVF) – stem cells derived from body fat – administered to cancer patients.

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The Agency said that such a product was potentially dangerous, and in a lawsuit brought against the CSCTC in 2018 argued a physician’s use of a patient’s own stem cells as part of the medical treatment provided to the patient was equivalent to manufacturing a biological drug product and therefore subject to regulation by the FDA.

But earlier this month, the Honorable Judge Jesus G. Bernal of the Central District of California sided with the CSCTC/Cell Surgical Network Corporation, ruling that the clinic’s surgical procedure using patients’ stem cells to treat a range of medical conditions does not fall under the FDA’s regulatory jurisdiction.

“The adipose tissue Defendants remove from patients clearly consists of human cells,” the court wrote. “And whatever is injected back into patients as part of Defendants’ SVF Surgical Procedure and Expanded MSC Surgical Procedure certainly contains such cells.”

The ruling was heavily criticized by advanced therapy industry and clinician group the ISCT, describing it as “flawed” and as inserting “regulatory uncertainty into the CGT market, creating opportunities for clinics offering purported treatments that are scientifically unproven and potentially dangerous to patients.”

The ruling claims SVF is essentially equivalent to surgery, which the ISCT said was both inaccurate and unsupported statements concerning SVF, and did not take into account the devices the clinics used to produce autologous stem cell-based interventions were not authorized or designed for stem cell production.

“Thirdly, the statement that culture-expanded mesenchymal stem cells (MSCs) should not be regulated as drugs conflicts with scientific evidence,” the industry group said.

“This statement opens the door to unchecked administration of poorly characterized and non-standardized cell preparations with unknown safety and efficacy and may pose significant risks to patients.”