A fitness guru named Ben Greenfield has now reported self-injecting non-FDA approved stem cells from US Stem Cell. He says the stem cells came from a clinic that lost a big federal court case 9 days ago. Greenfield posted a Facebook video of the actual injection, which he narrates. There’s some text along with the video. Together they raises many troubling questions.
Date of video vs. date of court ruling
Greenfield says in the text describing the video that the stem cells were sent to him at home. They are part of what seems most likely to me based on the text and the video itself to be a DIY self-injection kit. Greenfield indicates in the text that the cells came from the Florida stem cell clinic firm US Stem Cell via its affiliate US Stem Cell Clinic. Importantly, it seems to me as a non-attorney (I could be wrong) that the firms are now subject to effectively a temporary injunction. The Florida judge wrote this in response to an instant motion on June 4:
“ORDERED AND ADJUDGED that UNLESS AND UNTIL this Court enters a permanent injunction, pursuant to the terms of this Court’s Order on the Parties’ Motions for Summary Judgment, D.E. 73, Defendants SHALL NOT sell, provide or otherwise engage in any SVF therapy or any other activities to be regulated by the FDA as explained in the Court’s Order on the Parties’ Motions for Summary Judgment.D.E. 73.”
The original ruling came down on June 3.
It was some days later on June 8th when Greenfield posted the unusual video on Facebook in which he reports in the text of having recently received adipose “stem cells” from US Stem Cell Clinic, again a part of US Stem Cell, Inc.
The timing here could be really important.
What’s going on in the video exactly?
In the video, Greenfield seems to give himself an IV push of the stem cells. It’s hard to see what’s going on at times and to see his face in the video but it seems to be him and it’s on his FB page. You can see a screenshot from the video I’ve included below.
Here’s the text associated with the video, emphasis mine:
“*WARNING* For anyone uncomfortable with needles, please skip this video. I’m not a doctor, and what you will see in the video below is not to be taken as medical advice. But – from getting full body stem cell makeovers (Learn more here: http://bit.ly/2I4EyXW) to getting stem cells injected into my junk (http://bit.ly/2I3wRBt) to doing crazy blood stem cells protocols like this (http://bit.ly/2I5kO6B) – I have done some interesting things with stem cells…
In the video below, you can see me demonstrating how I inject mesenchymal stem cells extracted from my own adipose tissue by the US Stem Cell Clinic (https://usstemcellclinic.com/greenfield/). This is a fringe way to keep my endogenous stem cell pool elevated as I age, but it certainly does the trick…”
Big questions arise from Ben Greenfield stem cell DIY poke
I’ve got a lot of questions. Back to the timing issue, did US Stem Cell, et al. send him the stem cells and other materials after they lost the federal court case? There seem to be 4-5 days in between the court events and the video posting, but it’s also possible that Greenfield posted a video taken some days or weeks earlier.
Another caveat here is that at times Greenfield might somehow not be describing entirely accurately what is going on in the video and in the text. Last year, Greenfield openly discussed injection of his penis with stem cells from the company too (what he mentions in the text above as “stem cells injected into my junk.”) In addition, US Stem Cell Clinic has a webpage on Greenfield (see link in the statement with the video above).
More broadly, setting aside for the moment the timing issue, is it legal at any time for US Stem Cell Clinic or any other firm to ship an unapproved biologic product to a customer and importantly also one apparently intended for self-administration?
Does Greenfield live in a state other than Florida? I couldn’t figure that out yet. If so, then the apparently unapproved stem cell drug product may have been shipped across state lines, which could be significant. Again, I’m not an attorney, but these things do seem notable.
Dead or living cells in injection, and what about cryo chemicals?
Some practical issues come up here too in my mind as a stem cell biologist. Did the shipment use liquid nitrogen or dry ice? Did Greenfield store them properly? Were they alive? Were they thawed carefully without contamination?
Furthermore, if you mix stem cells with pure water as seems to be indicated in the video, they will literally pop open due to osmotic differences. Then they’ll be beyond dead and just debris. Perhaps Greenfield meant isotonic saline instead of water?
Also, cells are typically frozen in a special solution often containing DMSO or other cryopreservatives. Those specific chemicals may not (A) be intended for in vivo use, and (B) be safe to inject into one’s bloodstream.
Serious possible risks
My opinion is that this kind of practice is likely to be highly risky including a chance of infections (note that Greenfield doesn’t wear gloves for instance), immune reactions, or customers having other serious, acute adverse reactions with no medical personnel around to help.
Company leader Kristin Comella herself seemed to mention in a striking FB video last year that reactions such as fevers and passing out do happen at times after adipose stem cell injections.
What if no one is around to help or call 911 after a DIY stem cell self-administration causes major side effects?
I’ve heard some rumors more broadly for a half dozen or more years that some stem cell clinics including in Mexico sell purported stem cells expressly for the purpose of self-injection via shipments to customers, but evidence has been scant. Then there is or was the mobile stem cell clinic in Florida. Is it still scooting around?
How many people might be following Greenfield’s example using stem cell clinic cells shipped to them and what does the FDA think of this kind of thing?
It sure does feel like the “stem cell wild west” out there still.
Also see my broader review of genital procedures called P shots and O shots that are supposed to yield sexual enhancement. The data do not support these procedures.
I love it , I have a video with self-injection of Sheep DNA… we need more biohackers.
@admin – Check this one out. The guy giving the injection is the CEO of One Stem Cell Lab. It doesn’t seem like he has any medical training at all. https://www.facebook.com/DiverseHealthServices/videos/live-stem-cell-shot/970948673091978/ https://www.onestemcelllab.com/aboutus I still think the FDA is drinking water through a firehose at this point in time. I am pretty sure that guys like this couldn’t care less what the FDA says.
Paul, this guy is the same person who injected his penis with SVF on video and then talked about how his sex life improved….consider the source. Intelligent, rational people don’t do things like that, especially on camera. It’s like the “Jackass” movies but with cells. This is, of course, just my opinion, but it’s sad what people will do to garner attention. And these sorts of “testimonials” do not change the fact that, before this “product” was released to the public, no placebo-controlled, double-blinded clinical trials were ever done to establish safety and efficacy, the product is not being produced under cGMP conditions, and no characterization is apparently being done of the product to establish a functional definition of what it actually is. SVF contains MANY cell types, and MSCs are only one component of SVF. Where is the data showing that the SVFs being administered fall within any sorts of guidelines in terms of MSC dose? What are the release criteria for the product? Are there any? Are there written and validated SOPs dealing with procedures and protocols?…according to the FDA, there are not. Is sterility testing even done on the product before it’s administered to human patients, and has shipping under their conditions been validated as not compromising product quality? Where is the data showing that one can ship suspended SVF cells for home administration without compromising the quality of the DRUG? US Stem Cell seems to completely avoid and ignore these completely legitimate points in favor of “My Cells, My Choice” T-shirts and irrelevant rants about personal freedoms being violated. YES, people should have the rights to use validated, tested, and approved products, and they DO, but this product meets none of those criteria. They seem to miss ALL of that.
There is a process for bringing a human therapeutic to market: pre-clinical experiments that ensure that the product is safe and has a reasonable expectation of working as it is intended, human safety trials, clinical determinations of dosing, and assessments of side effects are all done by the legitimate clinical researchers. US Stem Cell bypassed literally ALL of those steps. The absolutely incompetent and negligent blinding of patients through faulty clinical design and literally NO pre-clinical data to show that this product was an option for macular degeneration shows you what kind of people you’re dealing with. If you are going to claim you’re bringing hope to the sick, you need to do far, far better than that.