Clinic versus clinic? Internecine conflicts among direct-to-consumer stem cell firms

Stem cell clinics marketing non-FDA approved therapies directly to consumers have been in various tense situations at times with the FDA or academics over the years, but more recently these stem cell clinic-related firms also appear in conflict with each other sometimes. The most notable recent example of conflict involves Dr. Christopher Centeno of Regenexx very strongly and publicly criticizing a firm called Stem Cell Institute of America.

Regenexx blog
Screenshot from the Regenexx blog, circles added by me.

Centeno is vocal on his Regenexx blog about stem cell-related various issues. He is outspoken in other ways too and my impression from his comments over the years is that he’s not exactly a fan of academics like me who weigh in on stem cell clinics. Interestingly, lately some of his posts have included strong criticism of other stem cell clinics including especially Stem Cell Institute of America, which is involved in the marketing of amniotic stem cells via scores of “partner locations” that seem to be amniotic clinics selling to consumers in this case. For example, you can see this strongly worded review of Stem Cell Institute of America by Centeno back in 2016 subtitled, “Chiropractic Amniotic Bait and Switch.” The Philadelphia Inquirer described his criticism as “blistering”:

“On his blog, Centeno has written blistering critiques of chiropractor-run stem-cell enterprises, particularly Stem Cell Institute of America, a Canton, Ga.-based firm that shows hundreds of “partner locations” on its online map.”

Already in 2018 Centeno has also done other posts on Stem Cell Institute of America and raised questions about a new “documentary” film series that apparently promotes unproven stem cell offerings including adipose stem cells (see screenshot above from his blog).

In fact, Centeno has what seems to be his own investigational type video (see above on YouTube) that asks the provocative question, “Is this stem cell fraud?” The video using the word “fraud” even in the form of a question is surprising and has certain risks attached to it.

I asked Centeno by email why he has stepped up his challenges to certain clinic-related businesses on his blog as well as via his video, and why he’s critical of the chiropractic amniotic stem cell area. Here is what he wrote back:

“Orthopedic stem cell therapy using bone marrow concentrate (BMC) has gained a reasonably large following with academic physicians at Stanford, Mayo, and Emory all offering this as a treatment for MSK conditions outside of clinical trials. Hence, it’s close to the point of gaining enough academic street cred to transition into common use. The chiropractic and amniotic “stem cell” trends threaten to take a serious field with mounting evidence and turn into an alternative medicine “pixie dust” therapy. This damages the credibility of orthopedic BMC use.”

Strong words.

So what’s Stem Cell Institute of America’s take on this situation?

I emailed to ask Brent Detelich, who is in a leadership role at Stem Cell Institute of America, for comment on Centeno’s various criticisms on his blog, etc. and got back a few emails from the organization with some critical words for their critic, and this comment for The Niche:

All Clients of the Stem Cell Institute of America have the purpose to educate patients about all forms of stem cell therapy, including adipose derived MSCs, bone marrow derived MSCs, human umbilical wharton’s jelly and other types of treatments such as PRP and Amniotic Tissue Matrix.  Amniotic has a particular quality of cells and growth factors which create healing activity.  The Stem Cell Institute of America does not dictate which choice of the above regenerative therapies it’s clients chose to use with their patients. The decision of which regenerative choice is best for each individual patient is a medical decision and not the place of a consultant.  The medical decision of how they diagnose and treat each patient lies with each office’s medical team. These medical decisions are only made after complete history, consultation, examination and any necessary X-rays or MRI studies are done.”

I have a feeling we haven’t heard the end of this story.

To be clear, I’m not taking sides here in this specific situation. Over the years I’ve been skeptical generally of amniotic stem cell” offerings and adipose stem cell “therapies”, but I’ve also asked questions about some of what Centeno and Regenexx clinics are or were doing with bone marrow cells (e.g. I reviewed a paper of his here and noted its hard to interpret the data due to lack of control subjects.)

More broadly, why would those in the for-profit direct-to-consumer clinic sphere (clinics themselves and affiliated businesses) seem to be more often in conflict with each other? One factor is that it’s getting crowded out there. You can see data on the spread of new U.S. clinics in the recent paper from Leigh Turner and I here.

Also reflecting a cramped direct-to-consumer clinic sphere, I’ve noted that many of these firms including Stem Cell Institute of America (see Seattle Times ad for them) are now using mainstream media ads for non-FDA approved offerings. These ads are very expensive so the firms must think it’s worth it to get consumers aware of them.

Another possible explanation for clinics getting into it with each other is that certain businesses may be firm believers in their own approach (e.g. one specific kind of stem cell type or methodology) and view other stem cell offerings with skepticism. Certain firms may be concerned that others that they view as problematic in their opinion could give their field a dent to its reputation overall.

It’s also worth noting that some stem cell clinic firms are going the opposite direction and linking up together, even as others are in conflict.

We are likely to see more examples of direct-to-consumer stem cell clinic businesses butting heads with each other in coming months and these situations may provide new insights into the overall direct-to-consumer stem cell clinic dynamic.

8 thoughts on “Clinic versus clinic? Internecine conflicts among direct-to-consumer stem cell firms”

  1. The products usually do not contain living cells, to prevent the regulatory issues with BLA designation. Thus, the cell counts are only reflective of a certain amounts of cell-derived growth factors and other proteins, which can be in direct correlation to the actual amount of cells per volume of the product prior (!) to its processing. However, sales representatives and other marketing materials often confuse these issues and distinctions, making direct correlations between cells and their products efficacy. Regenexx products are indeed in a tough competition with other BMAC companies and Dr. Centeno is very protective in his promotion of his product and methods.

    1. Thank you Dmitry, you have clarified my foggy memory. You are also causing me to ponder the broader issue of when a sales representative should be held accountable for not knowing the product that he/she is selling… In other fields (which I understand very much better than cellular biology) I am too often dismayed by accidentally-on-purpose, convenient errors.

  2. Brian: the amnion product that you refer to is the amnionic membrane, which enclosed the fetus suspended in the amniotic fluid. It’s a tough membrane that is easily harvested from placenta after birth. It’s been used in cell culture research to study the abilities of cancer cells to get through a basement membrane, which they have to do to invade organs. I used it myself, many decades ago. The membrane is “decelluarized”, usually with treatment with detergent, and is used for its structural properties, not for stem cells. I’m on vacation…far away, but when I get back I’ll try to figure out what these clinics are actually using.

    1. Thank you Jeanne, it seems I got my fluids and membranes mixed up. It is interesting that the literature has reports cells obtained from amniotic fluid that have many stem cell attributes:
      It just shows have careful us non-biologists have to be in order to properly decode phrases like “.Amniotic has a particular quality of cells…”

  3. The key point made by the representative of Stem Cell Institute of America is this:
    “Amniotic has a particular quality of cells and growth factors which create healing activity.”

    Do measurements provide supporting evidence for stem cells in amniotic fluid?

    Probably they do if you are talking about fresh-from-the-womb amniotic fluid.

    But if the Stem Cell Institute of America used it fresh-from-the-womb then they would be done like the burned dinner that I just cooked for the Missus.

    Some time ago I looked into the details. I didn’t keep a record, but I remember my conclusions. The commercial amniotic product which was approved by FDA was processed in a way that would kill any living thing so stone dead that even Jesus Christ herself could never have revived those poor little stem cells.

    Subsequently there have been several teams that have done the laboratory work to prove the flaming obvious. I don’t know if any of them ever published their findings in the formal literature. If not, they should!

    There is no need to sit on the fence.

    I’m half tempted to enroll in one of those educational seminars put on by the Stem Cell Institute of America. But I’d need to have you with me Paul, as my special cellular advisor. I’d want to have Dr Centeno with me also, as my medical advisor. Otherwise, they might pull the wool over my poor blind eyes and inject my arthritic knee full of bulldust…

    1. The “Amniotic stem cells” area overall can be really confusing. As Jeanne mentioned the use of the membrane itself for research is interesting and I don’t know how far it’s gotten but there are proposed (or maybe now proven or least trials underway?) structural clinical uses as an intact membrane that as far as I know would not make the amniotic membrane considered a drug by FDA. However, living isolated cells from amnion would be a drug I think. Many firms selling “amniotic stem cells” often market it to patients as “stem cells” sure implying they are living stem cells in there, when the cells might not be living or not stem cells or neither. What some think is inside the “amniotic stem cells” product injected into patients is actually a frozen (dead) extract of amniotic membrane itself. Whether that’s a drug or not…I don’t know.

      See here: and here and also here for my take (about 1/2 way down) on FDA’s most recent amniotic-related guidance:

      1. Amniotic membrane without cells is NOT considered a drug and has plenty of encouraging clinical foot/ankle research done and being done if one only looks. Per FDA section 351/361 rules , if a company advertising living cells in amniotic membrane OR breaks it down into ANY injectable form, a biologic drug has been created…requiring an IND/BLA. Paul, you would have done well and a tremendous service to your readers to do a little research on the founder of the Stem Cell Institute of America…it is publicly available by googling Brent Dieterlich, DC. Their business model is primarily geared towards adding “stem cells out of a bottle” in a chiropractor’s office…with the injections given by a nurse…at least in Texas, DC can not inject humans so they have to hire a medical director and then a nurse. The public seeing the infomercials and going to their seminars should be made aware of the founder’s entirely non-academic legal history and be able too judge their source of “medical information” accordingly.

Comments are closed.