Weekly reads: BioViva & life-extension clinic, RMATs, universal cells

I’ve written before about Liz Parrish and her life-extension firm BioViva. Now they appear to have connections with another entity called Integrated Health Systems or IHS, according to a new Wired article.

Some of what is going on with IHS and maybe BioViva in Mexico seems extremely risky to me.

BioViva, Parrish, and Integrated Health Systems

The Wired piece by Frank Swain raises many red flags.

One thing that stands out to me is the reported administration of unproven gene therapy into vulnerable patients’ brains.  In my view that has big risks including causing brain tumors.

According to Wired, former U.S. stem cell clinic doc Jason Williams is also a leader in these efforts. I’ve written before about Williams and Parrish for years. STAT also covered this BioViva effort two years ago.

I’m going to do a whole post on Liz Parrish, BioViva, and IHS in the near future. Stay tuned. Their hope seems to be to reverse cognitive decline such as that associated with Alzheimer’s but that seems unlikely to happen.

FDA has never dropped a granted RMAT

The Regenerative Medicine Advanced Therapy or RMAT designation has been a tool for the FDA to use to speed up its process for evaluating promising new biologics. You can check out my list of approved RMATs in the public domain.

Recently the FDA posted a list of the RMATs that it has withdrawn or rescinded by year since the program started.

There have been none. Ever.

I guess once the agency grants an RMAT things generally have gone well.

Universal cells approach, more stem cell news

• Stem cells treat diabetes without triggering immune response in mice, New Scientist. This is a similar overall idea to what some others are doing such as with Universal Cells and Clade Therapeutics. Universal Cells was acquired by Astellas.
• Maryland Stem Cell Research Commission Announces Over $14 Million in Awards to Accelerate Cures, PR.
• First UK baby with DNA from three people born after new IVF procedure, Guardian. I’ve written for many years about this technology and my concerns. Few data have been published on efficacy or safety of this approach, which has sometimes been called 3-person IVF, 3-person baby technology, or more neutrally “mitochondrial transfer.” That last name kind of gets things backwards.

• Astronauts’ blood samples to shed light on stem cells and cancer on second all-private crew mission, ISS.