Can a stem cell clinic business get FOOD AND DRUG ADMINISTRATION RMAT designation? At least one announced it was trying, but now has given up.
Stem cell clinic business ALL OF US Stem Cell, Inc. has reportedly introduced that it is at least temporarily abandoning its initiatives at getting Regenerative Medicine Advanced Therapy (RMAT) status from the FDA. The company’ s penny stock $USRM has been gyrating for months and I had earlier wondered if could be some fake news regarding i t. The USRM news now appears real and not good on the RMAT front. Shares dropped earlier this week (see earlier stock graph above).
As to plans, here’ s something from a good apparent company PR:
“ Till then, U. S. Stem Cell will focus on starting new clinics around the country to better serve patients within need. In addition to the original Sunrise clinic (that has effectively treated hundreds of patients and generated over $2m within revenues in the past 12 months alone), recent clinic openings consist of Miami and Palm Beach, Florida. Upcoming openings consist of Dallas, Texas (thanks in part to the early adoption associated with patient rights by the State of Texas), Chicago, The atlanta area, and Denver – as well as other clinics in the northeast as well as the west coast. ”
Opening a lot more clinics… selling non-FDA approved offerings?
This can be what the company sees as a good business move, however in my opinion it puts more patients at potential danger and takes their money for “ stem cellular treatments” that are not conclusively proven to be safe or efficient. I have not seen RCT data from USRM to aid their commercial stem cell efforts.
So what happened with the US Stem Cell, Inc. RMAT application? We might never know for sure, but rejection by the FOOD AND DRUG ADMINISTRATION is one possibility. Over at the RAPS site, a new piece on CBER has this particular to say (“ Marks” refers to CBER Director Peter Marks):
“ Thanks to the modern world Cures Act , FDA now has a new status for regenerative medicines, known as the regenerative medicine advanced treatment (RMAT) designation. As of last week, Marks said there have been nineteen requests for RMAT designations, 18 of which CBER offers acted on, and four of which have been granted… ’
Unless US Stem Cell, Incorporation. is the 1 out of the 19 applications on which the FOOD AND DRUG ADMINISTRATION has not acted, then it’ s not looking guaranteeing for their RMAT just based on the odds. Another possibility will be the FDA did not reject it, but asked US Come Cell for a lot more data and that constitutes “ served on”.
It’ s worth the reminder that this business was linked to the blinding the vision of three patients in a presentation at a 2016 FOOD AND DRUG ADMINISTRATION meeting and in a NEJM publication. The company has had individual lawsuits too, which seem to have been settled out of courtroom.
More broadly in the oversight arena, to a knowledge the FDA and CBER specifically have not released any warning letters to or taken other activities (at least in the public domain) on stem cellular clinics in ages despite hundreds of this kind of businesses marketing unproven stem cell offerings without FDA approval. And whatever happened to those 4 key FDA draft guidances? Does CBER have enough financing and staff to tackle the burgeoning stem cellular business arena? It remains unclear how the FDA plus CBER will handle key challenges under the new Trump administration and with new FDA Commissioner Scott Gottlieb.