Many stem cell clinics are in a bind in 2017 in the new RMAT approval reality.
Stem cell clinics say that they only want to help people by providing stem cell therapies to patients in a speedier way that they claim getting FDA approval for a trial just doesn’t allow, but that doesn’t ring true. It never has and now even less so.
The new RMAT designation out there based on the 21st Century Cures Act whereby the FDA can rapidly accelerate truly promising stem cell therapies in clinical trials makes this stem cell clinic excuse of the need for speed seem even less based on common sense. For more on RMATs see this background post. With RMAT, one eligibility criterion for that designation is that the illness in question must be serious or life threatening. The clinics have generally indicated in the past that what they treat are serious conditions. Will the FDA see it that way? It’ll depend on the conditions in each case.
The FDA has already approved 4 RMATs in just a few months so they are not holding back. If you really have good, solid clinical data for a serious or life-threatening condition, then you should apply to the FDA for an RMAT and in theory you can have both speed and FDA approval for a trial to move quickly. This new situation makes that general stem cell clinic marketing pitch of needing to get supposedly truly promising stem cells to patients more quickly than the FDA system allows ring very hollow.
Clinical speed with no real data is kind of like driving a race car with no brakes.
And if you are a patient, before you consider getting any stem cell treatment you have a new additional “must-ask” question for the clinics out there: “Have you applied for an RMAT from the FDA?” or “Do you have RMAT approvals?” Also, see my stem cell treatment guide for patients where I list 10 more questions to ask and things to think about. Asking your primary care doctor who is not involved in the stem cell treatment for their professional take in advance on your consideration of a stem cell treatment is a good idea.
If there is one thing that offends me, it is the idea of some bureaucrat delineating “serious or life threatening”. Who is to say what that really means?
http://www.healthline.com/health-news/suicide-attempts-high-among-arthritis-patients#1
To my way of thinking, the way that the line is drawn has always seemed both arbitrary and inconsiderate — and arrogant, to boot!
Of course, I’m not just picking on the American system. One only has to look at the legislation in Canada regarding assisted dying to see ignorance and arrogance raised to extreme farce!