It was interesting to hear a few months ago that Dr. Chadwick Prodromos, who runs a few stem cell clinics including one in Chicago, was at a D.C. roundtable on regenerative medicine put together by HHS Secretary RFK Jr.
More recently we heard that Kennedy got stem cells in Antigua. Since Dr. Prodromos also runs a clinic there and reportedly had participated in Kennedy’s roundtable, I wondered: could he have given Kennedy the stem cells in Antigua?
I’ve also been curious about his experience at the Kennedy regenerative medicine roundtable in March.
Prodromos Stem Cell Institute (PSCI)
In the past I had seen that the Prodromos Stem Cell Institute or PSCI markets stem cells for many conditions.
A piece about Kirk Cousins getting stem cells outside the U.S. also mentioned Prodromos a while back.
Given his possible connection with Kennedy, I thought it’d be useful to have a conversation with Dr. Prodromos. I reached out and he kindly agreed. Below is our email interview.
Even though we see some things about regenerative medicine differently, these kinds of dialogues are important for the field.
Interview with Chadwick Prodromos: connection with RFK Jr.
- Were you at RFK Jr.’s March regenerative medicine roundtable in DC? If so, can you tell us your impressions of the gathering? Is there a particular reason you were invited?
CP: Yes I was there and made a presentation. RFK Jr had asked me to come to present ideas on how to make bona fide evidence based stem cell treatments available in the US without allowing a “wild wild west” environment”: IE with safeguards against scams and non-scientific applications. I was happy to be provided the opportunity to provide suggestions in this regard. It was also of interest to hear the thoughts of the other attendees.
I believe I was invited because he saw that we perform high quality, safe clinical research, follow all applicable laws and regulations, and was aware that we are evidence based in our treatment. And with our work in Antigua we have been able to treat, generate reliable data, and safely help people, in a private setting that could perhaps be a model for expanded use in the USA down the road.
- Did you give RFK Jr. stem cells in Antigua or have any role in that procedure, which he voluntarily disclosed in a recent podcast where he mentioned getting stem cells in Antigua?
CP: Yes, I was the provider of that treatment in Antigua
PSCI offerings
- I noted a variety of regenerative services mentioned on the PSCI website. Can you clarify which products (stem cells, PRP, etc.) are offered for which medical conditions inside the US?
CP: We provide PRP injections in the US for arthritis of the knee, shoulder and other joints, and for some tendon problems: eg Achilles tendinitis or lateral epicondylitis (tennis elbow).
Years ago we treated arthritis with autologous bone marrow aspirate on the same day without more than minimal manipulation which follows US law, combined with same day autologous “nanofat” IE fat that was not digested with collagenase but was only washed, sized and centrifuged, again in accordance with FDA guidelines. Although we had significant success and no serious adverse events, we stopped performing it in 2019 because we felt we would likely be able to get even better results using cultured cells: which however could not, and cannot, be legally performed in the US, and we turned our attention toward providing cultured cells offshore.
The other services listed are umbilical cord derived cultured allogeneic mesenchymal stem cell (MSC) infusions and injections and MSC secretome (exosome) infusions. These are not legal in the US, except for topical use, and therefore we do not perform them in the US. The exception is when we obtain FDA compassionate use authorization for patients who must be treated in the US. For example, just two weeks ago we provided intra-thecal MSC injection for a quadriplegic patient in the US, with compassionate use FDA authorization, as this patient could not be transported to Antigua.
- I also found that you are the Director of this IRB. Is that the same IRB that gave approval to your study published here:? It sounds like the same IRB but I wasn’t If so, can you explain how that’s permissible? How would one avoid a COI in such cases?
CP: It is the same IRB. It is fully permissible under applicable regulations, which we closely follow, for a foundation to establish an IRB to review its studies. It would only be impermissible if there were a COI, which there is not. Regarding the potential COI question you raise regarding the screen shot you sent: that screen shot of the IRB link page shows the research team at our foundation, including myself, but not the IRB members.
It says medical director under my picture, but that refers to me being medical director of the foundation, not the IRB. That picture appears on every page of the website as a non-changing list of the foundation team members. It was on the IRB page you screen shot but it is also, for example, on the blog page, and does not bespeak a connection of the team including myself to the IRB, or the blog. The pages change as one navigates, but the “team” picture remains the same. No one who is in those pictures, the foundation “team,” including myself, serves on the IRB; and the IRB has only fully independent members who review and rule on the studies and who are not in any way connected to the foundation.
- A search of Clinicaltrials.gov found 30 trials with you as the contact. These seem like very diverse trials. Can you tell me about your philosophy with doing so many diverse trials? Are you intending to complete all these trials?
CP: Regarding completion of the trials: every patient we treat is enrolled in a clinical trial intended for completion and ultimate publication. Some of the trials, for example our back/neck or autism studies, generated enough patients to result in acceptable clinical series size for publication – which both of these are. And we have a number of others which have been submitted for publication or will be very soon. Other trials have only a few patients who we identify who meet criteria and these studies may result in a case report publication or no publication at all. We have not withdrawn these studies because we would treat if enough patients were found to complete our enrollment. IE, we intend to complete these trials if sufficient patients who meet inclusion criteria are identified.
Our philosophy in performing these diverse trials: we endeavor to study and treat disorders, even if diverse, where patients are suffering, where there is evidence in the literature of likely efficacy and safety and where we can treat safely, eg with iv infusion or joint injection. In the interests of safety, we do not treat or use study methods – e.g intra-vitreous injection – where there is some risk and where we do not have clinical expertise. We are careful to use validated rating instruments for each, and each patient is followed up diligently, short and long term by our full time research team.
Our ultimate goal, our philosophy, is to make stem cell treatment available to those who are likely to benefit from it and to generate data to facilitate making such treatments more widely available to those who need them where they are shown to be safe and effective. There is, overall, relatively little good published stem cell and exosome data, as you know, and few private centers follow up their patients and study them as we do. We believe, therefore, that it is incumbent upon us to publish our data to help advance the field.
Future of FDA oversight of regenerative treatments under Kennedy
- Looking ahead, with Kennedy leading HHS and a new team of leaders at the FDA and its CBER branch, how do you think oversight of stem cells and other regenerative materials by the agency might change? Are you optimistic about this field in the U.S.?
CP: I have been impressed that Secretary Kennedy is interested in helping people who need it with responsible stem cell treatments, but in a controlled manner that prevents, as best as is possible, ill- advised use, which unfortunately, even now, occurs as you know. I think the agency will still provide stringent oversight. He has made that very clear to me and I am absolutely in agreement. However the cost of IND studies is enormous as you know, perhaps averaging 19 million dollars per study. Certainly good studies are absolutely necessary to protect the public, but we believe they can be accomplished at reduced cost, if properly designed, without compromising their ability to protect the public. The high cost of most current studies greatly limits the number of studies performed because only pharmaceutical companies or difficult to fund investment groups can usually pay that.
And pharma/investment groups do a great job with their studies under FDA auspices. However, my goal is that we maintain strict oversight with rigorous studies, but decrease the costs of the studies so that more bona fide IND studies can be done by more qualified investigators who may have more limited budgets, generating more data and allowing more people to be helped.
Regarding being optimistic: having spent time talking with RFK Jr about this, I am indeed optimistic, because I have found him to be data driven, ethical and conscientious.
Japanese system as a model?
7. You mentioned possible changes to U.S. clinical studies on stem cells to make the whole process more affordable and efficient. Can you say more about that? For example, do you envision a conditional approval-type system like in Japan? Other ideas? Is this something the FDA leadership might be working toward now?
CP: The Japanese conditional approval system with their post-marketing studies is worthwhile. The more important area however, in my opinion, is within the execution of USA INDs.
The current United States FDA IND study process, while very good at ensuring safety, can be streamlined to greatly reduce cost and accelerate the timeline for approval of safe, effective regenerative medicine products, especially stem cells and exosomes, while still rigorously ensuring the safety of the American populace . This streamlining is accomplished generically in two ways: 1. eliminating unnecessary steps, and 2. executing necessary steps at reduced cost – while always maintaining highest standards to ensure safety. We are working on a detailed blueprint to lay out how this can be done. Secretary Kennedy is committed to increasing access without compromising safety and within a controlled environment that protects the public from a “Wild Wild West” uncontrolled environment.
Perinatal product oversight
8. Do you think it’s possible in the next few years that we’ll see the FDA allow some perinatal cell therapy procedures (cells, exosomes, etc.) to be marketed in the US without an IND or BLA? Or with reduced oversight compared to now?
CP: In my opinion unrestricted use of these products without FDA oversight would be unwise and is not likely to occur. Appropriate oversight protects patients and qualified providers from the unqualified. But it can be much more rapid and less expensive than it currently is so that safe patient access is greatly enhanced.
Good questions; candid answers – much appreciated!
Thanks for this. It is very insightful.