Bad Batch podcast’s dark picture of perinatal stem cell industry

A screenshot of a video of John Kosolcharoen at right and Alan Gaveck at left both of Liveyon, now featured in the podcast Bad Batch.

I finished listening to the first 6 episodes of the Bad Batch podcast last week. The series is by medical journalist Laura Beil. I think there will be a 7th episode that’s a Q&A.

I highly recommend listening to the series even if parts are wrenching at times like how much patients and families have been hurt. It’s important to know that reality and to hear directly from the real people who’ve been hurt.

The podcast focuses in large part on a supplier called Liveyon that sells non-FDA approved and in my view scientifically unproven umbilical cord “stem cell” products. I put “stem cell” in quotes because more broadly for perinatal products it’s not always clear if they have real living stem cells in them. Liveyon sells the product to care providers who then inject it into patients for many different conditions.

The firm’s owner, entrepreneur John Kosolcharoen (pictured from a video), as well as the patients and families harmed by a contaminated Liveyon product are the main real-life characters in this story. Bad Batch paints a stark picture of the unproven perinatal stem cell clinic industry and its suppliers.

You can read more about my sense of the podcast here, but in today’s post I want to focus on why I think Bad Batch could be bad news for perinatal stem cell clinics and suppliers overall.

For me the podcast showed in a convincing way just how much the unproven perinatal stem cell clinic universe is about making money and how little there is in the way of evidence of possible concrete benefit to patients. It was powerful how Beil juxtaposed Kosolcharoen having a newly purchased Rolls Royce in one part of the series with the moving stories of patients and families.

I was curious what Kosolcharoen thought of the podcast so I asked him for comment and here’s what he said:

“I think Laura did a thorough job investigating the story, but it’s very disappointing that after more than 6 hours of interviews and numerous texts, my deepest and sincerest apology to everyone who was affected was never aired, and my comments were cut up and selectively overlaid with a narrative that only shed negative light on an industry with great potential.”

Call me crazy, but going beyond an apology how about refunding the money that patients spent on all of the earlier questionable product from the outside vendor Genetech that was recalled and that in some cases made some patients so sick?

Now that would make quite a statement, but I don’t expect a voluntary refund.

Beil says toward the end of the podcast series that Liveyon if anything is doing better than ever now despite the news of the harmed patients. Wow. How can that be? I wonder how much settling all those patient lawsuits cost the firm? Did it have some kind of insurance coverage for these kinds of suits?

This growth of the firm with its now in-house “stem cell” product is occurring even as in my view it operates outside the bounds of normal clinical trial-based medicine and apparently is not much affected by the FDA oversight.

Without getting into arcane FDA regs, in my opinion it seems that Liveyon’s product (assuming it is indeed composed mostly of living umbilical cord cells) is more likely than not an unapproved drug. Indeed, the older version of the umbilical product from Genetech was described as such in the FDA warning letter to that firm.

So why hasn’t the agency done more here? It’s hard to know. Traditionally, you’d think a firm would have to prove their allogeneic stem cell product works and is safe to the FDA before selling it to doctors to inject into patients, right?

I hope the agency biologics regulators are listening to Bad Batch. It humanizes what’s at stake here.

4 thoughts on “Bad Batch podcast’s dark picture of perinatal stem cell industry”

  1. John Kosolcharoen – You say you are sorry, but actions speak louder than words. Your actions do not show you are sorry. What have you done for the families in which you have caused extreme hardship, pain, and tragedy? Waive their bills for the vials full of infection, lacking actual stem cells, causing unbearable amounts of pain and irreversible damage? Did you happen to reimburse them for their emergency hospital treatment, pay for future care, or do anything to help them and their families with the on-going suffering you have caused? They will never have their normal life back. Does that ever cross your mind? You owe the people you affected more than just an apology. Please, stop talking about how unbelievable your product is for a moment, and do something to help these individuals.

    Editor’s note: this comment was slightly edited to be compliant with The Niche commenting policy.

  2. The white paper graph shows there are only 1% stem cells with a standard deviation of 1% (CD34, CD90, 3% on CD73). Since the product is 10 Million nucleated cells, 1% would mean a max of 100,000 stem cells, with the deviation down to 0. The paper also says when they thaw they have 80% still viable. So best case 80,000 to 0 stem cells. What it does have is a lot markers for WBC’s (CD45) and the adhesion molecule (CD31) which are markers that a low # would be better unless this was used on cancer? possibly? The white paper is also documenting the growth factors and the one that stands out is the IL-1ra which is an anti inflammatory protein. So it appears that this would be anti-inflammatory, WBC drug at best. Not clear if these levels are high enough to work for a whole body…. does not appear to have enough stem cells to do anything other than be rejected if the HLA’s did not match well.

  3. Apparently no one has an opinion about this. Liveyon has been warned by the FDA in several matters before. I hope PK can shed some light on this. Every time I think it is safe to wade into the stem cell pool for treatment, it seems that the industry is full of bad actors. PK, you endorse some treatments. Are you free and clear form endorsing those treatments, as in you don’t make any money on them. Someone tell me that this treatment can be as good as the some of the data show. Or is everyone using forums like this to promote their own product and bad mouthing their competitors?

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