We’ve seen a spate of news stories this past year that can’t seem to separate good physicians using orthobiologics and physicians and other clinics who are taking advantage of patients. Let’s dive into a story put out by the Minneapolis Star Tribune this past weekend and venture some guesses as to why this is happening and go into solutions.
The History of the Problem
The regenerative medicine landscape has always been something of a big conundrum. On the one hand, we have new technologies like platelet-rich plasma (PRP) and stem cells that can revolutionize care. The data on PRP is as robust as any traditional orthopedic procedure offered and is better than knee replacement, meniscectomy, and rotator cuff repair. The data on bone marrow concentrate is developing and is improving year over year with both Mayo and our group publishing RCTs on its use in knee arthritis (1,2).
The FDA drew a line in the sand a decade ago about what was allowed under the practice of medicine in this arena and what was not. Meaning what would be regulated by state medical boards and what would need federal regulation as a drug. In the meantime, we have the university bench science crowd who don’t like any of it. Why? The clinical use of stem cells threatens basic science research grants. Pretty simple.
The Bench Scientists Have Increasingly Been Right
On the one hand, while opposing the clinical use of stem cells because that takes money away from basic science grants is their motive, the bench scientist crowd isn’t completely wrong about this disorderly field. In late 2015 I coined the term “Stem Cell Wild West” as I increasingly saw crazy treatments being offered that made little scientific sense. Since then things have spun further out of control. These days, for every 20 clinics offering stem cells, there’s likely only one trying to do it right and 19 that are either outright fraudulent or have very low-quality offerings that make no scientific sense. Hence, the bench scientists have been increasingly right. Getting media attention on the stem cell wild west is a good thing.
Defining Good from Bad Actors
Several years ago the FDA coined the terms “Good and Bad Actor” as it applied to stem cell therapy. This was a great idea, but they failed to define who was who. So how do you place clinics in one basket or the other?
Many physicians have come together to begin defining these categories. The group has been growing and now includes many academic physicians and private practitioners. First, the group tackled:
- Clinics Claiming that Amniotic and Umbilical Cord Tissues have Stem Cells
- Alternative Medicine Clinics performing Stem Cell Procedures
More recently, a Delphi panel was assembled to determine the best practices that define a good actor using bone marrow concentrate. More on that once we review the most recent Minneapolis Star Tribune story.
The New Stem Cell Story
The story published by the Minneapolis Star Tribune is pretty typical and features a physician story that’s become all too common in the stem cell wild west. The doctor’s name is Matthew Thorson, M.D. and he operates Stem Cell Centers of Minnesota. Dr. Thorson was sanctioned with a fine by the Minnesota State Medical Board for the following stem cell related charges:
- Advertising a cure for conditions including COPD and neuropathy and stating that stem cells could reverse and repair damage caused by these diseases.
- Paying a marketing company that ran seminars with professional salespeople as presenters. He paid this company on a per-patient generated basis.
- These seminars provided inaccurate information about what services his clinics offered and misrepresented the clinical research on stem cells.
All of this is egregious behavior and warrants a professional sanction. So clearly, the Minnesota State Medical Board identified a bad actor. In addition, in this case, the state regulation of the practice of medicine worked well. However, how do you define a good actor?
The Delphi Panel
The Delphi method is a way to get people who don’t often agree on the same page. It works well with doctors because getting 10 in a room usually generates 11 different opinions. In this case, the goal was to identify the best practices for the use of bone marrow concentrate in orthopedics, which is discussed in the Star Tribune story. About a dozen academic physicians and a dozen private practice doctors served on the panel.
Bone marrow concentrate (BMC) is made from taking a patient’s bone marrow aspirate and isolating the stem cell fraction. It’s been used in orthopedic care since the 1980s, so this is not new. It’s commonly been used in treating bone disease and now more commonly in treating damaged tendons, ligaments, and arthritis symptoms.
What did the panel decide?
- Clinics should use a treatment registry
- They should provide candidacy grades to patients (i.e. everyone is NOT a candidate for these therapies)
- They should use expanded informed consent (meaning that patients need to be informed of the risks, benefits, and alternatives when considering an investigational therapy)
- They should publish research on new orthopedic applications and use an IRB
- Advertising should be grounded in science (i.e. claiming that you can treat severe arthritis by growing a new joint is not based in any known clinical research)
- Imaging guidance should be used to place cells
- The minimum level of evidence needed before using BMC for new orthopedic applications should be a case series to a comparison trial
The Delphi panel findings and methods have been submitted for publication to a medical journal.
Regenexx and the Star Tribune Article
Because we’re big with about 70 nationwide clinics and because we have been very successful in saving companies money by using less invasive orthobiologics instead of invasive surgeries, we frequently get dragged into these stories. That happened in this case, where the reporter mentioned that we have a clinic in Minnesota and that we have gotten self-funded companies to pay for these therapies. Let’s dig in.
First, Regenexx has always abided by the findings of the Delphi panel. Meaning that we have always exceeded these guidelines and used even stricter controls. Hence, using these best practices suggestions decided by a group of academics and private practitioners, we’re a good actor. In addition, we use FDA compliant therapies. This is why we’ve been successful in securing national contracts with Fortune 500 companies to use less invasive interventional orthobiolgics instead of orthopedic surgery. We do this the right way.
The upshot? At the end of the day, it’s very difficult for health and science reporters to identify good versus bad actors in the stem cell wild west. One way that will happen is to use the adherence to best practices guidelines created by academic panels just like the Delphi group described above. In addition, state medical boards should stay vigilant in identifying abusive providers.
(1) Shapiro SA, Kazmerchak SE, Heckman MG, Zubair AC, O’Connor MI. A Prospective, Single-Blind, Placebo-Controlled Trial of Bone Marrow Aspirate Concentrate for Knee Osteoarthritis. Am J Sports Med. 2017 Jan;45(1):82-90. doi: 10.1177/0363546516662455.
(2) Centeno C, Sheinkop M, Dodson E, et al. A specific protocol of autologous bone marrow concentrate and platelet products versus exercise therapy for symptomatic knee osteoarthritis: a randomized controlled trial with 2 year follow-up. J Transl Med. 2018;16(1):355. Published 2018 Dec 13. doi:10.1186/s12967-018-1736-8