The decision will have widespread implications for the cell and gene therapy (CGT) sector as well as for patient safety, says the International Society for Cell & Gene Therapy (ISCT).
The judgement is flawed, according to the industry organization. It said the decision has inserted regulatory uncertainty into the CGT market, creating opportunities for clinics offering purported treatments that are scientifically unproven and potentially dangerous to patients:
“The ruling reinforces the imperative market need for informative resources that establish scientific consensus, standards, and best practices,” commented ISCT president, Jacques Galipeau.
Background
Late August saw a US federal judge, Jesus G Bernal of the Central District of California, issue a landmark decision siding with the California Stem Cell Treatment Center (CSCTC) and Cell Surgical Network Corporation, in a lawsuit brought by the US Food and Drug Administration (FDA).
The FDA took the legal action against CSCTC in 2018 to assert regulatory authority over stem cell therapies. The agency’s position is that taking a patient’s fat and digesting it with an enzyme to isolate the stem cell fraction creates a biologic drug that requires full FDA approval.
The court rejected this argument. Instead, the judge accepted CSCTC’s position that its treatments qualified for an exception from FDA regulations, in part because they were tantamount to surgical procedures.
The court wrote: “The adipose tissue the defendants remove from patients clearly consists of human cells. And whatever is injected back into patients as part of [the] defendants’ SVF surgical procedure and expanded MSC surgical procedure certainly contains such cells.”