Fact-checking Regenexx: reviews, data, & cost

Stem cell clinic firms often come and go rather quickly, but a few like Regenexx have persisted and even become a brand name.

I’ve been writing here on The Niche for more than eleven years about stem cell clinics. Regenexx has been around that whole time along with its founder Dr. Chris Centeno. Patients have regularly asked questions about the firm and approach. Does it work? How much does Regenexx cost? What might be the risks? In the bigger picture, is it worth trying overall?

The goal of today’s post is to try to answer such questions and in that way in a sense do an overall review of this brand.

Regenexx stem cell clinics
Map of Regenexx stem cell clinic locations. Screenshot of map from company website tool that allows you search for providers.

What’s in this article

What is Regenexx?Views of Regenexx More than a placebo? | Temporary benefit?Regenexx cost is $1,500-$9,000 | Medical literature | Overall review | References

Quick Article Summary and Claim Review. The regenerative medicine clinic firm Regenexx claims that bone marrow concentrate or PRP can aid in specific orthopedic conditions. The literature on this biologics approach to issues like arthritis and tears is conflicting. Although some papers by the firm and other groups that might be relevant report possible generally small benefits, they often lack placebo controls and blinding. Some other publications have in contrast shown no clear benefit. The injections are also expensive, but cheaper than joint replacement surgery. However, insurers generally do not cover the Regenexx kind of approach, while joint replacement is covered. Although the Regenexx products as administered by the clinics have reported relatively few adverse events in the literature, which is good, and it appears safer than offerings of many other clinics, you should talk to your personal doctor about possible risks and decisions.

What is Regenexx?

Regenexx is a regenerative medicine clinic firm that germinated in Colorado. They now have clinics throughout much of the U.S. See map above. According to a NY Times article there were 53 Regenexx clinics in 2019, but a recent blog post by Centeno reported almost 100 clinics. They clearly are growing fast still.

Early on they were most well known to me for bone marrow cell injections for orthopedic conditions. They would amplify the marrow cells in a lab and then administer them back to patients with ortho problems like arthritic knees or sports injuries. FDA regulations and a court case forced a switch to non-lab-grown cells within the U.S. As a result a satellite site using amplified marrow cells was established in the Cayman Islands outside FDA jurisdiction.

Now the Regenexx clinics also often use a form of something called platelet rich plasma or PRP. My impression is that PRP may now be used by Regenexx more often than bone marrow cells lately in the U.S., but I’m not positive about that. It may vary by clinic too.

The firm has also more recently been marketing stem cell supplements, which are included in my overall supplement review linked to in this sentence.

Views and reviews of Regenexx

Regenexx marketing, Regenexx cost
An example of Regenexx material.

Today you can find various Regenexx reviews on the web, but it’s hard to know whether they are balanced or marketing has tipped the scale.

I’ve based part of today’s post on a real response I wrote in the last few months to an actual patient asking about this approach for orthopedic conditions.

Patients often run into Regenexx marketing such as the screenshot I’ve included here.

I wonder how often this kind of interactive tells patients they are not candidates?

What is my own view? Read on.

More than a placebo?

I’m a Ph.D. scientist so I can’t give medical advice, but as a stem cell researcher I haven’t seen what I’d consider consistent solid data in support of Regenexx making a meaningful and lasting difference for many conditions.

Without much in the way of strong clinical trial data specifically on the Regenexx approaches it’s hard to know the chance of a real benefit over possible placebo effect.

At least reports in the public domain and in the firm’s published work make negative outcomes seem very rare compared to joint replacement.

Temporary benefit?

From the patients I’ve connected with over the years or seen talking about this on the web, oftentimes the possible benefits of these kinds of stem cells, PRP, etc. more generally seem to only last one or two months. This temporary effect is why I think it is likely mainly a placebo effect kind of thing in many cases.

On the other hand, the benefit could be real but short-lived due to, for example, transiently reducing inflammation. If so, this would require more injections for customers for many years.

The least plausible scenario to me is that a single Regenexx injection has permanent major benefits for most customers. Getting potentially many injections increases possible risks, but there’s another thing to think about with a series of injections. Cost.

Regenexx cost is $1,500-$9,000

Regenexx reportedly costs $1,500 to $9,000 a pop. That’s a broad range. I have often seen reports of people spending around $4K-$5K.

Even some fans of this kind of injection often find themselves admitting to getting them over and over because the injections don’t give a lasting apparent benefit as mentioned above. So to estimate real cost, you have to multiply the cost per injection by all these repeat injections. For instance, if you were to get five Regenexx treatments at $5,000 each, that’s $25,000.

Kaiser Health News noted that the Regenexx firm likes to compare their costs to the cost of knee replacement in the U.S. which runs around $20K-$30K. However, if all goes well, once you get that knee replacement there’s a good chance that you’re done except if you are a relatively young patient. And it’s covered by insurance. Regenexx is generally not covered by insurance but some self-insured companies do cover it for employees.

Some patients may rack up higher costs at Regenexx or other similar clinics via regular knee injections. The KHN report also noted examples of patients who got Regenexx and then had to have subsequent knee replacement anyway after that because of persistent knee problems so that’s another way costs can go way up. You could pay for both stem cells and then also knee replacement in such a scenario. An important question to ask is how many stem cell clinic patients end up permanently avoiding joint replacement?

Notably, side effects seem higher for joint replacements than for Regenexx, but I’m not clear on the extent of high-quality, long-term follow data (as in five years or more) for the latter. One of their papers reported a low rate of adverse events (325 out of 3,012 patients).

In terms of stem cell supplements, Regenexx supplements are expensive (some around $80 for a small amount) and in my opinion as a stem cell biologist they are likely of no real benefit. The same is true of the other stem cell supplements out there in this space.

Reading the medical literature

I don’t see much strong evidence in the published literature more broadly to support exactly what Regenexx is selling in terms of long-term benefit. Other papers using similar but not necessarily the exact same methods and products report conflicting results.

Turning to the NIH’s PubMed literature search tool, I recently found 15 papers that mention “Regenexx.” Admittedly, that’s a striking number as compared to almost any other stem cell clinic in the world. Most do not publish at all. The articles on PubMed mostly have the Regenexx founder Chris Centeno as an author.

A recent Regenexx paper found no benefit of marrow stem cells or PRP for bone marrow lesions associated with osteoarthritis. They concluded, “Treating knee bone marrow lesions with intraosseous bone marrow concentrate and platelet products did not affect patient reported outcomes.” On the positive side at least they reported this outcome. How often do you see a stem cell clinic publish negative data?

Another one of their papers reported a trial design with randomization focused on rotator cuff injuries. This 2020 trial paper studied bone marrow concentrate or platelet products (forms of PRP). They reported a possible benefit of these “orthobiologics” but without better controls than exercise alone (e.g., blinding or a placebo control,) it’s hard  to know if there’s reproducible efficacy here.

An earlier paper by Dr. Centeno reported possible benefits of bone marrow stem cells specific for knee pain. But again in my view it was not conducted in such a way that one could be sure of the results.

This uncertainty from papers with possible hints of efficacy but from trials that don’t produce high-level evidence is typical more generally of papers by stem cell clinics across the U.S. that publish. With the Regenexx studies, we generally just do not see use of placebo controls, only some use of randomization, and no blinding. These factors are especially important clinical trial design features for for-profit sponsors.

Overall Regenexx review

As you might have already gathered, conclusively fact-checking Regenexx is difficult without more high-quality data.

I’ve seen Centeno point out that the alternatives to what they are selling are limited and have issues.

It’s true that knee replacements and other non-regenerative orthopedic procedures are no picnic. There’s pain, sometimes difficult recovery including physical therapy, and more. Still, the bottom line is that joint replacement mostly works to make patients happy with improvements in their lives and mobility. The UW page I linked to two sentences back reports a >90% success rate for knee joint replacements.

In the end it seems like there’s no clear answer as to whether Regenexx is worth it.

If there is a benefit, my guess is that it’s relatively small and transient for most people and repeated shots would be necessary. I suppose for some patients that might be fine. They may feel that getting knee (or other) stem cell or PRP injections for a while may be preferable to immediately replacing an entire joint or if, for other orthopedic conditions, standard options like steroid injections aren’t helping enough.

I wish there was more data specifically on Regenexx itself that included controls and long-term follow up.

I personally would lean against trying it. Let’s see if they publish more rigorous data that might sway me.

Some final notes

  • This post is not meant as medical advice. Talk to your doctor who is not affiliated with this kind of clinic to get their view before making a decision.
  • While Dr. Centeno founded Regenexx and remains its CMO, it was sold to Harborview Medical Services Pc. Some of their clinics today may not have the same experience or perspectives as the original team.
  • Given how much money they are making, I’ve said for years that they should bite the bullet and do placebo-controlled, randomized, double-blinded studies. So far I haven’t seen that.
  • As a stem cell biologist I have no conflicts of interest relevant to this article. It really doesn’t matter in any concrete way to me if Regenexx or its competitors in the stem cell clinic world are successful or not. I’m focusing on educational outreach.
  • An interesting side note is that Dr. Centeno has become one of the most outspoken critics of other stem cell clinics and suppliers, particularly those in the birth-related sphere and/or with chiropractor involvement. Some positives including raised awareness have come from that pushback by him writing on the Regenexx blog even if those folks are competitors in a general sense. And, yes, I am including this final comment even though he has been critical of me on his blog.

References

  1. PubMed search for Regenexx on October 5, 2021.
  2. Clinicaltrials.gov search for Regenexx on October 5, 2021.
  3. A 2021 paper by Regenexx.
  4. Another 2021 paper by Centeno that examined umbilical cord products.
  5. NY Times article on Regenexx.

7 thoughts on “Fact-checking Regenexx: reviews, data, & cost”

  1. I find your research and reviews are based on facts not fiction of some sorts like William Shatner that fooled the world to Jo into Stem Cells therapy with little or not gain.
    Jeff

  2. Have you found out anything about how long the cells you got remained in your body? The studies I’ve seen all indicate that the cells are gone within days. That is relevant to understanding how they might work.

  3. This is a well-reasoned response to Mr. Centeno’s successful decade-plus of stem cell therapy. I mean, financially at least… but I have to say I am not cynical enough to believe such a run could be possible without some consistent positive and sustained results.

    I believe at least SOME of the reason people are pleased is they have some reduction in pain level without the risk of surgery. Even at the 10% failure rate for replacements you cite (and we know it’s often higher), who wouldn’t be happy to find another way.

    I believe additionally people make lots of changes at once when going through the surgery exploration process, so some of the benefits attributed to stem cell therapy may be other anti-inflammtory measures such as diet or exercise improvements.

    Not saying there’s not some placebo effect, but I definitely don’t see how a progressive chronic pain condition like I have could dramatically decrease in less than 2 weeks – from 900mg gabapentin to 0mg needed (still plenty of pain, but manageable with lifestyle/supplementation/OTC). Now, my condition is CNS-related from lumbar puncture (with negative results & unnecessary as it turned out), so not orthopedic. But I had 0 expectation of results, just a “hail mary” as my pain was progressing beyond the point I could deal with it even with drugs (and side-effects thereof). I truly was desperate and for 10 days I had 0 belief it did any good. On day 11, I realized I didn’t need gabapentin after 20 months. 4 years later (and 1 more round of stem cells 3 years ago), I’m still managing, with gradually lower pain levels as I push the envelope. Something changed for me back then. I don’t know what, but I won’t shut up about it because I know it was stem cells and I only did what I did because others had shared their story. There are MANY of them even from M.D.s who personally experienced dramatic results (happy to share links). So, yeah, all anecdotal, but when there’s no chance of a big patentable drug or any kind of FDA approval and subsequent $$$, who’s gonna spend that $1,000,000,000?

    Not sure how credible this comes across. I have a simple medical history with clean mri, so it may just be that I had inflammation levels that were marginal (yet pain was high due to its central nature). Somehow that IV was enough to reach across BBB (maybe just signaling, not entire stem cells, who knows?) and make a subjective difference.

    I don’t believe stem cells *directly* make a whole ton of macroscopic difference regeneratively from what I’ve seen as a lay person. But, if they reduce inflammation that can translate to a WHOLE lot less pain. Think of a swollen finger that you bump on something… pain is disproportionately related to inflammation, no?

    And, less pain can definitely lead to improved function over time as blood flow increases with movement, etc. And, most likely the inflammation had been preventing the normal regeneration that happens every day in all of us (and the pain was hindering sleep, which is a highly regenerative state).

    I don’t doubt a certain amount of placebo effect in any procedure, but to my mind, you aren’t accounting for the entire spectrum, the holistic impact that reduced inflammation and reduced pain can have on an individual.

    You’re looking for hard data we all wish we had, and I’m in agreement with that. I’m merely sharing my experience and best understanding I have of how I could have had that experience, given the science I’m seeing. And, about 15 other people I know out of the 30 who have tried it that I personally know for my condition would share equally positive stories. Some far more miraculous, from bed-bound due to pain to working again.

    In short, if stem cells address inflammation (I know we don’t know they can), there’s no reason they can’t transform a joint or a life.

  4. As a patient (happy) of IV autologous stem cells (both marrow, and adipose on separate occasions) for a non-orthopedic condition, I was told under no circumstances to use NSAIDS or steroids for at least several months after the procedure. The whole idea is to let the stem cells address inflammation; if you tamp down inflammation, you could (potentially anyway – no research I know of) miss out on the anti-inflammatory and possible regenerative effect of the therapy.

  5. Paul, as you know, I am firmly in the “prove it” camp about all regenerative therapy. That applies to my own work as well.

    I’ve wondered about whether there’s been a comparison of PRP or bone marrow with steroid injections. Steroids injected directly into the knee or hip usually give relief for months, a similar time frame as the alleged regenerative therapy.

    To be regenerative, a therapy has to regenerate something. Steroids don’t induce regeneration or healing- they just reduce chronic inflammation. It appears that Regenexx treatment doesn’t regenerate anything, either, so it can’t be called regenerative.

    With no knowledge of exactly how the cell therapies are administered, I’m wondering if the injections include steroids. It would make sense even if the intention was to just tamp down the acute inflammation caused by the injection. If so, then the mystery about how the cells might “work” is solved.

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