FDA Files its First Injunctions against More Than 100 Stem Cell Clinics
​​​[Posted on: Thursday, May 10, 2018]

Yesterday FDA took an unprecedented action of filing complaints in Federal courts seeking permanent injunctions to stop two stem cell treatment groups from selling stem cell products, a decision that affects more than 100 clinics in almost 40 states. These two groups were in the news last August when they were raided by FDA inspectors and US Marshalls and were found to be in violation of GMP and clinical testing regulations. The two clinics had stayed operational since the FDA actions leading to questions about FDA’s enforcement plans. Yesterday, FDA answered the critics by seeking to permanently close these stem cell groups. One of these, the Cell Surgical Network, has partner clinics that cover literally the entire nation with more than 100 partners, and has additional operations in 15 other countries. In the complaints, FDA specifically included the leaderships of these groups in an attempt to assure that these clinics do not re-start in different names. The FDA complaint specifically refers to the stem cell part of the services, so the rest of the business of these clinics should continue. Also, so far no criminal complaints have been filed against any members of the leadership. Both these clinics had announced their plans to fight FDA actions in the past; it will be interesting to see how they follow through and defend themselves. The case would certainly have ramifications for all stem cell clinics offering unapproved treatments to patients in the US. Is this the beginning of similar FDA action against other stem cell clinics? These were special cases. US Stem Cells of Florida is the only clinic with reported cases of major adverse events linked to stem cell treatments while Cell Surgical Network was found to manipulate autologous stem cells with viruses. Both these cases are easier to prosecute. However, these are very different from an average stem cell clinic that isolates stem cells from fat tissue for local autologous injections such as in the treatment of joint ailments. In the past announcements, FDA had stated that it plans to allow stem cell clinics who offer low risk autologous treatments that involve local injections. FDA has stated that it is concerned with intravenous injections, which would severely limit the claims made by the providers of such products and services. Will FDA decide to use these cases as the precedence to go after other stem cell clinics? And what about the public opinion; past surveys have shown wide public acceptance of autologous stem cell treatments. Nonetheless, the legal outcome of this case will likely affect all stem cell clinics. There is increasing political interest for regulating stem cell clinics but with increased regulations comes increased cost of such treatments and potential delays in available therapies. The favorable public opinion could easily turn in the opposite direction if these cases become the start of a wider FDA crackdown on all stem cell clinics without an acceptable alternative to patients. No matter what the outcome, we certainly entered a new age of stem cell regulation yesterday.