It’s frustrating to see so much bad media coverage of celebrity trips to clinics to get supposed stem cell treatment of various kinds. Part of the concern here stems from ordinary people taking risks by following the example of the famous people. Good journalism should ask tough questions, talk to experts, and not yield an overall promotional result.
In today’s post I go through an awful news item on a Caribbean stem cell clinic.
A stem cell treatment?
Here we go. Kirk Cousins travels to Caribbean for stem cell treatment, Kare11. Note that this is a Minnesota TV news station.
What the celebs get is often called a “stem cell treatment” in the media like with this article.
What exactly is a stem cell treatment anyway?
Should we use the word “treatment” to describe the unproven stuff that is sold at most clinics? I don’t believe so. Treatment implies a known benefit when here there may be none. What is offered is typically not a scientifially validated treatment or therapy.
What’s the right word? “Intervention” may be accurate, but it’s clunky. Injection? Not all clinic offerings are injections but most are.
Kirk Cousins
Cousins got the injection at a clinic in Antigua and Barbuda run by a doctor named Joseph John. One interesting element here is that he went there at the recommendation of an American stem cell clinic owner:
“Dr. Chad Prodromos, medical director and CEO of the Prodromos Stem Cell Institute in Chicago, recommended the treatment. “
This rings a bell because I’ve stumbled on the Prodromos clinic in Chicago in past years. I noted its diverse marketing claims. Its website talks about anti-aging and treating autism, memory loss, paralysis, CP, and more. I am skeptical that the stem cells offered at clinics can safely and effectively do those things. As is now the case for many firms, this one has a presence both in the U.S. and in the Caribbean.
So another strike against this media article is that its main expert source is someone who runs a stem cell clinic. There are no other opinions or perspectives given. That’s just bad journalism.
Why is Dr. Prodromos promoting a Caribbean stem cell clinic?
Vitro Biopharma as cell supplier
The article (and video it includes) goes on to discuss more of what Prodromos said:
“He says the cells are from Colorado-based tissue bank, Vitro Biopharma, and says they’re safe and FDA approved. However, he says anyone seeking to use them needs individualized FDA approval, and that this process involves expensive clinical trials.”
That supplier name may seem familiar to The Niche readers. I’ve written before about how Vitro Biopharma also supplies another Caribbean clinic DVC Stem Cell.
Also related to the quote, the clinical trials mentioned as needed in the US and as apparenlty being bypassed by clinics in the Caribbean, are required at a biomedical science level to figure out if something works and is safe.
Other issues with the article
This media piece has other problems.
For instance, it doesn’t ask any questions. The author also fails to mention potential risks of the ‘stem cell treatment’.
I wonder if Kirk Cousins gets free or discounted stem cells for his trips there being used in a promotional kind of way. The writer maybe should have asked. They seemed to have relied on the video and other material for the article rather than digging into things themselves.
The issue of celebs potentially getting discounts or free stem cells at clinics also came to mind recently when a famous surfer went to Tijuana for unproven stem cells and kept posting about it, apparently even after his buddy who went with him died after getting stem cells at the same place. It’s still unclear if the stem cells had a role in the death.
Overall, the Minnesota media piece promotes going to Caribbean clinics for unproven stem cells. It makes such visits seem like vacations to fun places. We should expect much more from the press on stem cells.
Finally, since Prodromos is quoted in this piece on Kirk Cousins’ trip, I took a fresh look at his stem cell clinic website. What are they offering these days?
Prodromos clinic stem cell types
The Prodromos website says it uses both allogeneic and autologous cells:
“We use both. Specifically, we use autologous stem cells from fat or occasionally bone marrow from the given patient. We also use allogeneic cultured umbilical cord cells.”
As to the cultured cord cells, where does the Chicago clinic get them? I am not aware of the FDA approving any culture umbilical cord stem cells from Vitro Biopharma.
Regardless of source, are the lab-grown cells used only at the clinic locations outside the U.S.? I ask because to my knowledge there are no FDA-approved therapies using lab-grown umbilical cord cells for the kinds of things this clinic is marketing.
You can see my list of FDA approved stem cell and other regenerative therapies including gene therapies.
FDA approved Cell and Gene Therapy Approvals (including stem cells): https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products
These all have gone through RIGOROUS scientific study at multiple major intuitions and robust clinical trials to ensure they are both SAFE and EFFECTIVE.
The term umbilical cord often can mean couple of things. The umbilical’s cord blood has HSC and to a lesser degree MSCs. The umbilical cord tissue itself has MSCs.
It’s often unclear on the source as its often cited only as ‘umbilical cord’ without proper source reference.
There are no approved MSC treatments by the FDA at this time. The only umbilical cord HSC ‘approved’ by the FDA are for the reconstitution of the hematopoietic system and the immunological system (aka bone marrow transplant). There are no other approved uses. There are robust clinical trials around the world, with limited success (and most with mixed or poor results).
The repeat citations that these cells work, and work well, is not based in sound evidence based science. Testimonials, and reports from these unproven clinics, are not reliable data. These ‘clinics’ are driven by profit, and there is zero incentive to report results. There is massive financial incentive to make claims they work. It’s the proverbial ‘I have a bridge to sell you…’
These cells, both HSC and MSCs (from various sources) do hold tremendous promise. But the science is clear. Random preparations of any of these cells just infused into a patients body do not hold any real chance of curing or treating most of the conditions often cited by a ‘for profit’ clinic. Medical science, and indeed biology, is much more complicated than that.
Biotech and Bio-pharma have been researching and entering into clinical trials for a long time now. If the cells just worked by general infusion after culture, we’d have seen many remarkable results from said research and clinical trials. But we have not. What we have seen is a promise that with more research and development, eventually methodologies will arise to make use of their properties. But it is incredibly clear that just ‘injecting some cells’ doesn’t work.
These clinics prey on bad information, and greed from unscrupulous people. It’s watch an old school black and white movie with a snake oil salesman. Literally the same sales tactic. “IT works. So-and-so used it!” Or “The doctor’s don’t want to know, but…” and on and on. Its the same thing… and its pretty well established.
Check it out, the University of Miami is currently conducting a double blind placebo controlled clinical trial for the treatment of heart failure using umbilical cord MSCs. I’ll be watching this one closely.
https://news.med.miami.edu/innovative-clinical-trial-could-transform-stem-cell-heart-regeneration-therapy/
The FDA hasn’t approved MSCs, for good reason. Every MSC preparation is different, so it’s impossible to know what the effective aspect is, if there is one. Arnie Caplan defined MSCs as cells in embryos that could differentiate into cartilage, muscle, and fat. That definition is not relevant for any of these cells that are being used in unregulated, unapproved “treatments”. I think that “treatment” is a good word to use for this stuff. You can have a mud treatment, an avocado treatment – it’s just a thing that is done…not a therapy.
Caveat emptor is applicable in this situation, you are correct there are malicious, devious, “players” out there.
The science is real, and as in most complicated treatments, of which chemotherapy comes to mind, the treatment does not always result in “complete response” (CR).
There are noted clinical trials that have used MSCs with success, not every patient that has a treatment responds.
If one is searching for an MSC treatment then that person needs to do extensive “due diligence” in their effort.
A regenerative applications clinic that comes to mind that exhibits integrity and knowledge is located in Phoenix, Arizona. This type of detrimental effect would not happen at this clinic.
There are legitimate clinics that are using umbilical cord derived MSCs with success, within the regulatory environment in Mexico. The numbers of these clinics is growing. The regenerative medical clinic industry is growing world wide.
I hope that Mesoblast can meet the Phase 3 clinical trials and eventually have FDA approval for their proprietary cell line and be able to treat pediatric acute GVHD for children that do not respond to standard of treatment, steroids.
@Neil,
How would you define a successful clinical trial?
I could define a clinical trial to treat chronic GVHD, and what success would be would be defined by the results.
For example the clinical trial that allowed Rezurock to be FDA approved. There isn’t much effective for chronic GVHD, but one of the details in the results was that 20% of those treated had musculoskeletal pain as a side effect (which can result in stopping the drug, and be extremely debilitating). There were other side effects listed as well (the usual associated with a “pathway blocker” molecule), I have not read what the total responders numbers were; but it was not 100%. It would be interesting to do a statistical analysis of the information sent to the FDA which allowed approval.
The detailed protocol structure and plethora of defined results would determine success. As is understood a compound molecule may work for some but not for all.
One aspect, my opinionated perspective is that many people are seeking systemic treatment with MSCs, either via IV or ultrasound guided injection in the afflicted joint.
The majority are feeling relief, be it real or placebo. Some patients have compared blood assays before and after (such as liver enzyme numbers), experiencing improvement in symptoms. Thus the success of the results are drawing more people to seek this treatment despite out of pocket expense, and lack of FDA approval. The number of clinics offering “unproven through clinical trial” treatments with uMSCs is growing all over the world, along with the market value.
I suppose that success would be defined by a typical statistical result such as: number of non responders significantly less than the total numbers of partial responders plus complete responders total. Effective for 60 percent of clinical trial subjects might be a definition of success. I was told by the attending MD that when I consented to induction chemotherapy that there was a 60% survival of individuals in my age group (60-70).
So 60% was considered successful as defined by survival.
I would very much like to see a well defined, administrated, double blind, placebo cohort, controlled source and dosage protocol, multi center clinical trial using umbilical cord derived mesenchymal stem cells (uMSC) aka medicinal signaling cells (as the late Arnold Caplan PhD requested the name to be) for the application in chronic GVHD, and/or applied to rejuvenate the damage done to tissue and organs by chemotherapy and chronic GVHD..
It seems there is enough data from the past years to have individual MDs say that uMSCs are effective for pediatric acute GVHD. I have read many articles, review reports, and medical journal reports that indicate uMSCs should be further evaluated.
Here is an interesting review report:
January 2020, Stem Cells Translational Medicine journal, Title: “Trends in mesenchymal stem cell clinical trials 2004-2018:Is efficacy optimal in a narrow dose range?”
https://academic.oup.com/stcltm/article/9/1/17/6406756
Abstract:
“The number of clinical trials using mesenchymal stem cells (MSCs) has increased since 2008, but this trend slowed in the past several years and dropped precipitously in 2018. Previous reports have analyzed MSC clinical trials by disease, phase, cell source, country of origin, and trial initiation date, all of which can be downloaded directly from ClinicalTrials.gov. We have extended analyses to a larger group of 914 MSC trials reported through 2018. To search for potential factors that may influence the design of new trials, we extracted data on routes of administration and dosing from individual ClinicalTrials.gov records as this information cannot be downloaded directly from the database. Intravenous (IV) injection is the most common, least invasive and most reproducible method, accounting for 43% of all trials. The median dose for IV delivery is 100 million MSCs/patient/dose. Analysis of all trials using IV injection that reported positive outcomes indicated minimal effective doses (MEDs) ranging from 70 to 190 million MSCs/patient/dose in 14/16 trials with the other two trials administering much higher doses of at least 900 million cells. Dose-response data showing differential efficacy for improved outcomes were reported in only four trials, which indicated a narrower MED range of 100-150 million MSCs/patient with lower and higher IV doses being less effective. The results suggest that it may be critical to determine MEDs in early trials before proceeding with large clinical trials.”
As was said in Shakespeare “the lady doth protest too much, methinks” …..
I’ve written much here, but then again I have “skin in the game” …
Arnold Caplan PhD: https://thedaily.case.edu/faculty-member-arnold-caplan-passes-away/
Neil I’m not sure if you’ll see this but there are additional clinical trials using mesenchymal stem cells that you should be aware of.
In one clinical trial umbilical cord mesenchymal stem cells stopped the progression of type 1 diabetes.
https://www.reddit.com/r/Futurology/s/96qYuVz8Zm
UC Davis Health in California is currently running a clinical trial and they’re trying to cure spina bifida using placenta derived mesenchymal stem cells, according to the doctor who’s running the clinical trial the early results are highly encouraging. In fact recently they gave the go ahead to expand the trial to phase 2, which is a good sign.
https://www.reddit.com/r/Futurology/s/CaiTtomFtA
The University of Miami is currently conducting a double blind placebo controlled trial for congestive heart failure using umbilical cord MSCs, I’ll be watching this one very closely
https://news.med.miami.edu/innovative-clinical-trial-could-transform-stem-cell-heart-regeneration-therapy/
“Current therapies have limited efficacy, and we need better strategies to address this major public health problem,” he said. “Our goal is to challenge the treatment paradigm that stem cells must be delivered directly to the heart. That approach requires invasive cell delivery methods and effectively limits treatment to one dose. In addition, large quantities of MSCs are needed, as these cells disappear rapidly after administration to the heart.”
Under the double-blind, randomized trial, one group of participants will receive four IV infusions of MSCs, a second group will receive one MSC and three placebo doses and a control group will receive a four placebo doses. Results of the trial will be based on improvements in left ventricular function as measured by cardiac magnetic resonance imaging (MRI) scans.
“We believe infusing MSCs intravenously will reduce inflammation of the heart and circulatory system,” said Dr. Hare. “We also want to see if repeated doses will have a better effect than a single dose.”
I like this post, in the research I’ve done, it seems that the protocol that was effective were the multiple IVs over a span of time. The next treatment I will seek for myself is an IV of 150 million uMSCs, every fourth day, for four sessions. This protocol is derived from a few different review reports I’ve read, and select cases where the treatment was described and had positive results for the patient that it was applied to.
This form of regenerative translational medicine should be promoted by the NIH and encouraged by the FDA (set up a special “orphan” application criterion) to allow the refinement and development of protocols with the best outcomes noted.
A ‘tiger team” approach to fast track the use of uMSCs.