√ Dissecting Liveyon Fda Inspection Report Troubled Perinatal Stem Cell Industry

The perinatal stem cell clinic supplier Liveyon has had many issues recently including an FDA inspection that  in my view didn’t go well and which I’ll return to in a minute. First, some background on the company and this troubled industry.

Liveyon website screenshot.

E. c0l1 and other pathogens ended up in some of the Liveyon product somehow prior to injections of it into patients at clinics. There was the recall.  A dozen or more patients ended up in the hospital. Patients lawsuits stemming from that are pending.

Then there was the recent scathing (appropriately so in my opinion) investigational report on the perinatal stem cell clinic industry co-published by The New Yorker and ProPublica by Caroline Chen in which Liveyon featured prominently.

More broadly, the unproven perinatal “stem cell” industry is a chaotic but growing sector that in my opinion has little benefit to offer patients in the way of proven safe and effective products. It does pose many risks.

I’ve regularly covered this subsector of the larger unproven stem cell clinic field within the even larger overall stem cell ecosystem for years. It’s been hard to watch and in my view, it is not only generally bad for patients, but also is harmful to legitimate research on perinatal stem cells.

Liveyon has tried to reboot itself more recently with a “new supplier” (basically itself?). From Chen’s report:

“Now Liveyon is making its own product, from umbilical cords that it buys from a public cord bank, Kosolcharoen said. The bank, which he declined to identify, sells donated cords that don’t meet FDA standards for treatment of blood disorders, he said. Liveyon, he noted, uses them for a different purpose — to create stem cell products. He called the new treatment “clinical trial grade” and said that Liveyon plans to start trials to prove its safety and benefits. But, even before conducting trials, Liveyon is already marketing the product, which it calls Pure, with the tagline “The Pure Feeling of Healing.”

So circling back, some months ago, Liveyon was also inspected by the FDA. I found the 483 inspection report, which you can see here.

In my view the report isn’t good, to put it mildly.

Eight observations (I would translate the FDA-speak “observations” here to “problematic issues”) were listed including in my view some very serious ones. There are also more than 8 issues here overall as some of the observations have many separate bullet points such as “Observation 1” listing a number of serious adverse events.

Utan Cord Bank products screenshot from website.

Other specific issues mentioned by the FDA include deviations from proper testing and handling of their umbilical product. It’s not exactly confidence building.

The broader perinatal stem cell industry is very concerning and was a major focus of Chen’s article. Liveyon has some competition in this sector from other suppliers including perhaps most prominently the firm called Utah Cord Bank. For instance, a stem cell clinic doc named David Greene reportedly gets a product from Utah Cord Bank. Others do too. Chen spent a good amount of time digging into what Greene does and the history of Utah Cord Bank, including this telling passage:

“Around 2016, the bank began making two amniotic stem cell products, called StemShot and StemVive. (StemShot was later renamed Stemii.) Although the bank continued to store birth tissue, amniotic stem cells soon became its biggest moneymaker.

The Utah Cord Bank was co-founded by a man named Eliott Spencer, who holds a doctorate in biochemistry from Brigham Young University. When the bank started producing StemShot and StemVive, Spencer was the only scientist on the company’s management team and the only person who knew the recipe for making the products, according to two former employees who spoke on condition of anonymity. Spencer said in an email that the bank now has “more than one scientist and many technicians, as well as multiple people who know how to safely procure, process and package our products.”

Read Chen’s whole article. I highly recommend it.

Overall, in my opinion, the more we learn about the perinatal stem cell industry the clearer it becomes that it is risky for consumers and has a slew of problems. I believe that more action by regulators is urgently needed including the FDA, the FTC, and state bodies.

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√ Fda Cautions R3 Stem Cell 50+ Stem Cell Clinic Affiliates

Today the FDA put an Arizona firmed called R3 Stem Cell, LLC and its leader Dr. David Greene on notice that what they and 50+ affiliates centers are selling in the way of stem cells were not approved by the agency. R3 Stem Cell markets perinatal (birth-related) stem cell offerings on its website.

There’s a lot of subtext in the FDA letter and accompanying PR, in my view none of it good for the company or its “centers of excellence.”

The R3 website also includes a number of patient testimonials (see screenshot), but I cannot really tell how much hard biomedical science is behind what they are offering. My prediction would be not much. I just covered another similar supplier, Liveyon, and the wider perinatal stem cell clinic world here a few days ago in a piece that also quoted from an excellent article by Caroline Chen at ProPublica that had included some material on David Greene as well.

R3 seems to be an important part of the problematic perinatal stem cell subsector of the unproven stem cell clinic world.

Screenshot of part of an R3 Stem Cell patient testimonial video.

What I would call a “mini-warning” letter came in the form of an untitled letter that was further described in the FDA PR here.

A key passage from the PR:

“The U.S. Food and Drug Administration has sent an untitled letter to R3 Stem Cell, LLC of Scottsdale, Arizona, and its chief executive officer, David Greene, M.D. The company, through its affiliated centers or clinics throughout the U.S., offers unapproved stem cell products to treat a variety of diseases and conditions, such as Lyme disease, diabetes, Parkinson’s disease, stroke, kidney failure and amyotrophic lateral sclerosis (ALS). The products offered by R3 Stem Cell, LLC are not approved by the FDA.

The FDA has notified each of R3 Stem Cell, LLC’s more than 50 affiliate centers or clinics of this action.”

I appreciate the fact that the FDA included the 50+ clinics affiliated with R3 in the notice. This is kind of akin to the FDA Including the full Cell Surgical Network chain of clinics as a defendant in its suit again California Stem Cell Treatment Center.

You can read the actual untitled letter to Dr. Greene here.

The FDA noted that R3 Stem Cell seems to be suggesting that their stem cell products can effectively be used for some extremely serious health conditions that, in my opinion, cannot today confidently be addressed using stem cells including ALS and Parkinson’s Disease.

There is so much false hope being sold more generally.

The FDA further indicated that R3 Stem Cell’s product is likely to be a drug and thus by law it requires premarket approval. In other words, the product almost certainly needs FDA vetting and a cleared IND (and probably R3 needs a BLA) prior to being sold to and used in patients at the clinics.

FDA Acting Commissioner Ned Sharpless, M.D. had some strong words for the stem cell clinic field in this PR as well, which in my view likely reflect strong agency views specifically on R3 Stem Cell itself.

From CBER Director Peter Marks, we also got a nice summary of all the actions taken more broadly by the FDA recently on unproven stem cell clinics and suppliers:

“Over the past year, the FDA has sent 46 manufacturers and health care professionals regulatory correspondence, including today’s untitled letter.  We have also sent warning letters, and we have two court cases pending. We’re committed to taking appropriate steps to address those that jeopardize public health.”

I also like how the FDA gave practical steps that consumers or health care providers can take if they are concerned here:

“Health care professionals and consumers should report any adverse events related to treatments with R3 Stem Cell, LLC products and/or other stem cell treatments to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178. The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.”

This action definitely seems a step above the many “mini-warning letters” that the FDA has sent out in the past, which were never made public. Hopefully, R3 Stem will have to seriously reconsider what they are doing. I don’t know why the FDA sent R3 an untitled letter instead of a warning letter given the nature of the issues mentioned.

More letters of various kinds from the agency to clinics are likely in the works. I hope they don’t wait until next year to take more actual actions as well as many patients are still at risk.

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