FDA

Silence from FDA Commissioner Robert Califf on stem cell clinics is a problem

/ / 4 Comments
Robert Califf, FDA Commissioner

FDA Commissioners including Robert Califf have radically different approaches to the job including oversight of marketing of unproven stem cells. As to stem cell clinics, some have been very engaged, while others seem the opposite. During his second go as FDA Commissioner, Robert Califf has been vocal about many topics. However, as best as I […]

Silence from FDA Commissioner Robert Califf on stem cell clinics is a problem Read More »

Concerns after interview with Kyle Cetrulo of Perinatal Stem Cell Society

/ / Leave a Comment
Perinatal Stem Cell Society email material.

I recently interviewed Kyle Cetrulo of the Perinatal Stem Cell Society. This organization seeks to catalyze big changes in stem cell use and clinical trials in the U.S. In the interview, we touched on many topics including FDA oversight of the cell therapy space. Some of this discussion was in reaction to the new Utah

Concerns after interview with Kyle Cetrulo of Perinatal Stem Cell Society Read More »

Surprising new FDA remarks to AABB on cord biologics misuse & stem cell clinics

/ / 8 Comments
AABB, FDA

The Association for the Advancement of Blood & Biotherapies or AABB recently had a very useful Q&A with the FDA on cord blood use. There are some important new things from the FDA on the marketing and use of cord blood in there. The agency was also quite blunt in some ways about the challenges,

Surprising new FDA remarks to AABB on cord biologics misuse & stem cell clinics Read More »

BrainStorm Cell Therapeutics Hail Mary with FDA on Nurown for ALS

/ / Leave a Comment
MSF-NTF cells, NurOwn

BrainStorm Cell Therapeutics is developing Nurown, an investigational therapy intended for treating ALS. I recently posted about BrainStorm and its prospects for providing real hope on stem cells for ALS. I see it as a long shot. The ALS community needs real hope, but one challenge is determining how good clinical data have to be to

BrainStorm Cell Therapeutics Hail Mary with FDA on Nurown for ALS Read More »

Did US Stem Cell Clinic defy FDA injunction? New injured patient suit sparks questions

/ / Leave a Comment
Dr. Antonio E Blanco MD, US Stem Cell

It feels like I’ve been writing about the Florida clinic US Stem Cell for a very long time. The FDA has been aware of them for about as long. It was only after reports of patient injuries that the FDA at last took action on US Stem Cell and its subsidiary US Stem Cell Clinic. Several

Did US Stem Cell Clinic defy FDA injunction? New injured patient suit sparks questions Read More »

Review of ExoFlo paper used to push Direct Biologics IND inside FDA finds red flags

/ / 7 Comments
ExoFlo from Direct Biologics

I wrote recently about how political pressure on FDA Commissioner Stephen Hahn in 2020 may have helped the Texas firm Direct Biologics move their product ExoFlo forward inside the agency. Today I analyze the ExoFlo Phase I clinical trial paper used in that push on Hahn to get the firm the IND for a Phase II

Review of ExoFlo paper used to push Direct Biologics IND inside FDA finds red flags Read More »

FDA leader Stephen Hahn was pressured to aid Texas firm Direct Biologics

/ / 3 Comments
Former FDA Commissioner Stephen Hahn.

An FDA FOIA dump of text messages of former Commissioner Stephen Hahn suggests that a Texas regenerative firm called Direct Biologics benefited from political pressure on him in mid-2020. Then he was asked again to help in early 2021. This was shortly before he resigned at the start of the Biden Administration. The push came from

FDA leader Stephen Hahn was pressured to aid Texas firm Direct Biologics Read More »

Fact-checking troubling R3 Stem Cell clinic chain

/ / 12 Comments
Map of R3 stem cell clinic locations

I’ve had concerns about an American unproven clinic firm called R3 Stem Cell for many years. They sell unproven stem cell-related “treatments” via dozens of affiliated locations. I put quotes around treatments because in my view there is no good evidence here for claims of treating numerous serious illnesses. The goal of today’s post is

Fact-checking troubling R3 Stem Cell clinic chain Read More »