Stem cell clinics should file an IND, Now
[Thursday, June 25, 2020]

​Stem cell clinics should file INDs immediately, patients looking for stem cell treatments should only do so for those offered under INDs, patients should ask for informed consent, not pay for the treatment, and report adverse events. Or so FDA would want to see. In an article last week in the Journal of American Medical Association, two of the top FDA officials, the current Commissioner Dr Hahn and the Chief of the Center for Biologics Dr Marks, wrote that FDA is concerned about the stem cell therapies sold to patients in the country and that they would like to see the above changes in practice. However, the article does not mention any policy changes at the FDA or why is the FDA not shutting down clinics selling unapproved therapies to start with. For the last several years, FDA has many times raised concerns about unapproved stem cell therapies available in the US. A couple of years back, FDA announced that it would allow stem cell clinics and companies offering unapproved stem cell therapies till November 2020 to either file IND applications for their treatments or close business. FDA has also explicitly stated that bar a very small exception, all regenerative therapies require clinical trials under IND and market approval under Biologics License Agreements (BLAs) to be sold to patients. This includes not just therapies containing stem cells from all sources (fat, bone marrow, and umbilical cord) but other sources such as birth tissues (Wharton’s jelly), extracellular material (exosomes) and any other material of human, animal or cell culture origin used to provide regenerative therapies. Two years ago, FDA projected that by November 2020 it would have several hundred stem cell INDs. It does not seem that it happened. FDA has so far not taken any aggressive actions against stem cell clinics. It has issued a few Warning Letters to the most egregious companies but mostly has not enforced the law widely. The most common source of stem cell therapies are physicians offering such treatments to their patients. FDA has mostly stayed away from penalizing stem cell therapist physicians. All the FDA enforcement actions so far were on providers of services and products to help physicians offer stem cell therapies. The article last week pleads with the physicians to voluntarily stop the practice or do it under INDs. It also pleads with physicians and patients to voluntarily report adverse events associated with stem cell treatments or other complaints. But that may not be enough. There is no doubt that FDA will increase enforcement on corporate providers of stem cells therapies, as it has shown in the last few years. Lack of providers may force physicians to stop as well. FDA has so far kept its strategy to enforce secret but may be such articles by FDA brass offer clues. File an IND or else….