The FDA took some big action last week and issued a major statement today on stem cell clinics (see my post here). I asked Dr. Mark Berman of the Cell Surgical Network if he had any statement regarding the recent action and statement from the FDA today that involved flagship network member clinic, California Stem Cell Treatment Centers.
Dr. Berman sent me the new press release from Cell Surgical Network, which you can read here.
Amongst other things, the Cell Surgical Network PR makes some strong statements that I’ve got as bullet points below:
- The PR defended the work with StemImmune, which it said involved many top doctors.
- The PR said that the Department of Defense was involved.
- The PR said there was no charge to patients for participation in this particular interventional work. I’d be curious how it was funded then.
- It mentioned “multiple IDE and IND applications” having been submitted, which is notable. What is the status of these at the FDA? Wouldn’t the work with StemImmune require pre-approval from the FDA in the form of an IND (not just submitted, but favorably reviewed by the FDA), BLA, and more before experimenting on patients? In my view, it sure seems that way.
- The PR singled out FDA Commissioner Gottlieb, saying, “His comments show a lack of understanding surrounding autologous surgical procedures.” Really? That’s an aggressive statement in my opinion.
- It said regarding Cell Surgical Network interaction with the FDA inspectors, “After sharing with and educating the inspectors as much as we did…”
In short, Cell Surgical Network is responding vigorously to the FDA with this PR.
What happens next?