October 25, 2020

The Niche

Knoepfler lab stem cell blog

Stem cell shootout at the Texas Trib Festival including Celltex

The Texas Tribune held a liveblog regarding Health & Human Services at festival they were sponsoring.

A particularly testy, interesting exchange on stem cells occurred (see starting around 2:51PM)  involving Andrea Ferrenz of Celltex and Dr. Leigh Turner of University of Minnesota as well as Texas State Rep. Rick Hardcastle and David Bales of Texans for Stem Cell Research. The moderator was Scott Braddock and live blogger was Emily Ramshaw.

Hardcastle is a proponent of adult stem cell therapies of the kind that he himself received for MS and that Guv Rick Perry received for a chronic back problem. Hardcastle called his own stem cell treatment “miraculous” and said that Perry’s worked “OK”.

Many topics were covered in the livebog including stem cell tourism, which interestingly Hardcastle indicated he wanted to become a thriving industry in Texas.

One of the most interesting and intense exchanges was between Ferrenz of Celltex and Turner.

3:11 p.m. BY EMILY RAMSHAW

Ferrenz: Back in April we had two FDA inspectors come visit us. “They stayed with us for two weeks. They looked at literally everything we do… One of the things they saw was that cells go to physicians.” “We’ve shown them, through dialogues, through materials, that we fall into … this category that says we don’t have to go through a pre-approval process.”

3:09 p.m. BY EMILY RAMSHAW

Ferrenz responding to Turner’s allegations: “I feel like I’m doing a Food and Drug 101 class.”

3:07 p.m. BY EMILY RAMSHAW

Ferrenz: Says Turner made a lot of allegations based on misinterpretation of the law. 

3:04 p.m. BY EMILY RAMSHAW

Turner wrote a letter to the FDA about CellTex. “When it comes to CellTex, the reason I wrote to the FDA is that this looks to me like a clear example of a company that isn’t in compliance with federal law.” 

For months I’ve been talking to numerous experts on FDA policy and law as well as people deeply involved in the for-profit adult stem cell business.

Based on this, I find the comments from Celltex surprising.

Apparently, from talking to some of those present, the exchange at this stem cell meeting was particularly pointed with different sides exchanging sharp statements.

I’m hoping to have direct reactions to the meeting from Leigh Turner and Andrea Ferrenz for a post tomorrow.