Platelet-rich plasma or PRP is a regenerative product that has grown in popularity. The literature on clinical applications of PRP is all over the place. Whether it works or not for any particular application is unclear to me. Many orthopedists seem enthused about it. I haven’t seen any major adverse events linked to PRP.
PRP is often viewed more as a biologic rather than a drug. Perhaps then it’s unsurprising that PRP hasn’t sparked much in the way of FDA action.
With all of this in mind, a new FDA warning on PRP to Estar Technologies seems out of left field. Let’s start the week’s recap there.
But first, student Parmin Sedigh and I have a new educational video on the risks of stem cells. Take a look above and subscribe to our channels if you like the content. Also, my lab is still crowdfunding some of our children’s brain tumor research. Please consider making a tax-deductible donation. Thanks. These are tough research funding times.
FDA warning on PRP
Andrew Ittleman has a nice analysis of what makes this letter unusual and what it might mean.
The key quote from Andrew, “There is a clear disparity between the cleared indication (PRP preparation) and the indications for which Estar markets the device (specific treatments). However, even though “everyone else is doing it,” this is the first case I’m aware of where FDA is alleging that a PRP kit is adulterated and misbranded because the marketing caused a “major change or modification to the intended uses for this device” which “could significantly affect its safety or effectiveness.”
Many firms have done PRP kit marketing that seems to go beyond the “original intended uses.” So, is this broader warning signal on PRP just a one-off or a sign of things to come?
Colossal Biosciences is excited
Colossal Biosciences is growing chickens in a 3D-printed artificial eggshell, MIT Tech Review. Antonio Regalado has a solid take on this public relations effort from Colossal. As many The Niche readers might recall, I’ve been concerned about hype related to Colossal including their incorrect claim of having de-extincted dire wolves. I even gave them The Screamers science hype award for 2025. The new “news” here on an artificial egg is mildly interesting, but already seems hyped in the media. Is such an egg model really going to help with de-extinction of anything? Growing a giant moa-like bird in such an egg model is probably not going to work.
As I keep saying, focus on helping living but endangered animals rather than wasting resources on de-extinction.
Michael Hiltzik has a great take on the new PR effort: Are dodos and mammoths coming back from extinction? Don’t count on it.
Iowa AG wins again on stem cell clinics
Stem cell company must pay $2.5 million for false claims to Iowans, Des Moines Register. Bravo to state AGs overall on their successes against unproven stem cell clinics including in Iowa. They have been more effective than the FDA in some ways on the clinics.
From the AG’s office: Attorney General Brenna Bird Secures Victory Against Deceptive Stem Cell Company.
“Attorney General Brenna Bird announced a significant legal victory for Iowans following a district court ruling against Biologics Health, LLC, Summit Partners Group, LLC, and their owners, Rylee Meek and Scott Thomas. The court found the defendants engaged in unlawful conduct, finding twenty-seven (27) violations of the Iowa Consumer Fraud Act (including the Older Iowans Act) and the Iowa Door-to-Door Sales Act)…Preying on Iowans who are looking for pain relief or medical treatment is evil and illegal,” said Attorney General Bird. “Iowans deserve better; this decision sends a message to other con artists and fraudsters that deceptive trade practices will not be tolerated in Iowa.”
Strong words. I wrote before about this Iowa AG stem cell case.
More recommended reads
- Capsida says it still doesn’t know what caused gene therapy death, STAT. There have been several gene therapy-related deaths in recent years. This is such a risky space that as more people get emerging gene therapies, deaths and other serious adverse events are just going to happen. As the field continues to develop the hope is that such events will get even rarer.
- Evidence for coordinate CTCF and histone H3.3 activities in K27M diffuse midline gliomas, Acta Neuro Comm. The new paper from my lab sheds fresh light on the inner workings of these deadly childhood tumors, which used to be called DIPG. The ultimate goal is an effective treatment.
- Dark times ahead at the FDA, STAT. I think the FDA as we knew it is probably gone…at least for a few more years.
“Platelet-rich plasma or PRP is a regenerative product that has grown in popularity. The literature on clinical applications of PRP is all over the place. Whether it works or not for any particular application is unclear to me.”
I’d like to know why you think this, perhaps in a Q&A format with one of the PRP docs. What sort of evidence would be up to Dr. K’s speed, as opposed to what exists today?
From what I understand, PRP could be biologically plausible, but oftentimes when sham controls are introduced or a university attempts to replicate what clinics are saying, it fails? Is that accurate?
The instant counterpoint, typically by cash only clinic PRP doctors, is that they didn’t use “high enough” platelet counts which could be a good point, but I don’t see them backing that claim up with a similar sham controlled, third-party PRP trial that did quantify platelets. I’d be a bit surprised if this hasn’t been done seeing how many PRP trials there are, I just can’t seem to find it.
Additionally, even high platelet counts still yield a heterogenous mix of growth factors depending on the patient right? So even if platelets are counted, do we know the dosage of the active biologic and does that matter? If I’m way off on this please let me know.
Lastly, I’ve heard other counterpoints which seem bizarre but I could be wrong. One of which is the physician didn’t have the right skillset to inject properly. One of the big PRP docs often says often that nobody even knows if they’re injecting into a bursa or ligament, and this is what’s happening? And how they do it is company IP that they can’t reveal?
As a patient, I find this all confusing. Here’s an interesting video from Dr. Centeno noting that platelet lysate made his core stronger?
https://www.youtube.com/watch?v=0i_TEJNDnVA