The 21st Century Cures Act has some important regenerative medication language in it. One part of that was attempting to accelerate FOOD AND DRUG ADMINISTRATION review of promising investigation regenerative medicine therapies. The system for this was a new designation called Regenerative Advanced Treatment, now renamed Regenerative Medicine Advanced Treatment (RMAT) Designation .
I don’ to think anyone was sure how this would play out there in terms of how quickly the FDA would give RMAT designations and to how many investigational products. Already it’ s crystal clear the FDA seems to be embracing the spirit of the Remedies provisions as it has given out quite a few FDA granted RMAT designations and done so quickly.
The first which i could see was given to Humacyte, which has an synthetic vessel research program (see image). The artificial ships become colonized with endogenous stem cells after implantation.
Keep in mind that RMAT designation does not equal FDA-approval overall, but it should mean the investigational therapy offers solid data behind it and is promising, together equaling a faster FDA review and then potentially in the future acceptance should future data be strong. If some of the RMAT therapies are ultimately proven to be safe and effective, and via RMAT they were able to get to patients and help them faster, with few failures amongst the RMAT group, then the RMAT regulatory experiment will be proven a big success.
Here are the approved RMATs I could find so far:
There may be a lot more already given, but not yet in the public domain. If you know more please comment on the post to let us know and I’ ll add them.