FDA’s Interpretation of HCT/Ps is Subject to Legal Review - Federal Judge
​[Thursday, January 30, 2020] 
A Federal judge in California ruled that FDA’s interpretation of its own Guidance Documents regarding autologous cell therapy is faulty and hence subject to legal challenge. Specifically, the judge ripped through FDA interpretation of the “same surgical process” exemption for the regulation of Human Cellular and Tissue-based Products (HCT/P). The case in point was a legal challenge from a stem cell clinic in California to FDA’s injunction for autologous adipose stromal vascular fraction (SVF) treatment. In discussing his decision, the judge poked holes in FDA’s definition for autologous use, and minimum manipulation. FDA’s motion for Summary Judgement was denied letting the full trial proceed giving the defending physicians a chance to convince a jury in their favor. You don’t need to be a lawyer to read through the court ruling and see how the judge systematically dismantled FDA’s key arguments, setting the stage for a tough case for the FDA lawyers going forward. This is the first time a Federal judge seemed to agree with defending doctors’ argument that FDA over-extended its authority to close autologous stem cell clinics. FDA has long held a narrow interpretation of the HCT/P rule, particularly when applied to adipose-derived cell preparations, by claiming that any use of such cells, even autologous, is illegal unless it is approved under a BLA. Hundreds of clinics in the US offer various forms of so-called “stem cell” treatments derived from the patient’s own adipose tissue. Most of these cell preparations vary in their content of stem cells, if any, and most are prepared in questionable conditions. Over the years, FDA has issued Warning Letters, and other notices to clinics offering autologous stem cell treatments. However, the FDA’s motions in the above case did not discuss compliance with quality requirements or the intended uses of the SVF preparation, rather the definition of the HCT/Ps. This may just be one minor victory for the defendants in a long legal case, and one can bet that next time FDA lawyers will come better prepared. None-the-less it is a significant ruling as it potentially creates a narrow window where stem cell clinics can survive. Assuming that the ruling stands the test of the full trial, a clinic harvesting cells from a patient and re-injecting back in the same patient could keep offering these treatment provided they do not do any manipulation such as expanding cells in culture or altering cells by genetic or other tools. This could open a hole in FDA’s stated goal to close all stem cell clinics by November of this year. This case has the potential to be a landmark case of the kind that changed FDA’s rules for off-label promotion a few years back. Finger’s crossed.