For years and years, we were the only group offering orthopedic stem cell therapy that transparently published our results. However, this past year or two, we’ve been seeing some stem cell treatment websites begin to report their results (outcomes). So who can you trust? What’s likely too good to be true? This blog post is to help you become an educated consumer!
Rolex vs. Smolex
When I was a teen growing up in a firmly middle-class household, we couldn’t begin to afford a Rolex or designer clothes. Thankfully, our local Swap Shop (a big open-air market) took care of that issue. They had knock-offs of everything you could think of and more. Do you want a pair of $200 Fila Bjorn Borg tennis shoes? No problem; we’ve got you covered for $20. Want a solid-gold Rolex but can’t afford 20 grand? Here’s one for $20. In fact, the more I think about it, all of the knock-offs were about $20. Of course, the problem with all of these products was that they would last a few days or a week or two and then fall apart.
At least back in the day, when my mom bought these knock-offs to appease her fashion-sensitive South Florida kids, she knew what she was buying. Nobody who bought them really thought they were getting a gold Rolex for 20 bucks. Hence, we called a knock-off Rolex a “Smolex.” In fact, that became our slang for anything that was fake. However, with stem cell therapy today, we have Rolex prices, but knock-offs abound. It’s as if you went to a website you thought was the real Rolex site and put in your credit card number, and a few days later a Smolex arrives.
Traditionally, it’s been easy to spot the Smolex stem cell websites. They usually don’t have more than a few pages, and the harder you try to find substance, there’s nothing under the hood. However, we’ve now begun to see a few advertised outcomes. Some of the sites doing this even use real stem cell therapy. However, collecting real outcome data is not easy, and I’ll show you how that’s usually not what’s happening at these sites. Hence, understanding the Smolex outcomes from the Rolex outcomes can keep you from buying a treatment that’s more hype than solid.
What Do Rolex Stem Cell Therapy Outcomes Look Like?
Before I get into how to identify high-quality outcome data, you need to understand that stem cell therapy is not magic pixie dust. I don’t care what you have wrong with you or which treatment is used (WE’VE USED THEM ALL), there are always successes and failures. Hence, the easiest way to spot a fake anything is that it looks too good to be true. The same holds true for stem cell therapy for knees, hips, shoulders, ankles, hands, tendons, ligaments, and the spine.
Before you can understand how to spot a fake, you need to know what goes into the real deal. So let’s review what we do at Regenexx to collect outcomes:
The software infrastructure to collect results is unique. First, you need a custom piece of software, as none is equipped out of the box to collect orthopedic stem cell therapy outcomes. This will cost 100–200K off the bat for programming and employee time.
Next, you need a methodology. Meaning, which validated questionnaires will be sent to patients and when? We send ours at one month, three months, six months, and annually.
Next, you need validated questionnaires for pain, function, and percentage improvement. Each body area will need a different functional questionnaire that asks about how much the patient can do for any specific task. For example, for the knee, the questions might ask about walking up stairs or running. However, for the shoulder, the questions might ask about lifting something above the head or carrying groceries. Each one also has to have been well studied as being a valid metric.
Whom will you ask? Meaning, it’s much harder to ask the patients how they did, but you tend to get a much more honest answer. It’s easier to ask the doctor how they think the patient did, but physicians are hopelessly biased and often believe that their patients who failed therapy got better.
Now that you have an expensive custom-designed software system and a set of validated questionnaires to send, the next step is something that sounds very simple but is really hard. If you’re collecting pain and function, you need a preprocedure score. However, asking a practicing physician to change his or her workflow to get these forms filled out before the procedure is a HUGE issue. Hence, most clinics never master this one simple task, and as a result, the data being reported is less valuable because you have no idea where the patient started!
You still need humans! People get busy and don’t like to fill out forms. It interrupts their life. Hence, it’s critical that real humans bother them when they snooze an e-mail or text from your software system. While it’s easy to collect data and make phone calls in 20–50 patients, try doing this with the tens of thousands of patients we’ve been tracking at Regenexx since 2005! It’s a massive task.
You need to make sense of all of this information. We have a full-time biostatistician whose job it is to help us understand the data.
So as you can see, the Rolex version of outcome-data collection is expensive, resource intensive, and has a ton of moving parts. Now let’s look at the Smolex version.
The Smolex Version Looks Good on the Surface But Has No Substance
Here I’ll give you telltale signs that the data you’re looking at is poor quality and not likely to be representative of how you’ll do with your treatment (i.e., a Smolex):
It’s all about the n, baby! When we doctors talk about results, one of the most important things to know is how many patients we’re talking about. We call this number the “n” of patients. Hence, you want a big “n” (i.e., many, many patients) when discussing outcomes. For example, right now, on our live outcome-reporting tool, you’ll find the results of about 10,000 orthopedic stem cell therapies. There are also more than 4,000 platelet and stem cell-based spine treatments listed. Hence, if you see that a site lists 10–20 patients or doesn’t tell you how many patients made up the results they’re reporting, that’s a Smolex. Frankly, if it’s under 500 patients, I would be wary. I blogged on this yesterday, where a website advertising BioRenew PTM Therapy had three datasets. One had 11 patients, one didn’t report how many patients, and one had 17 patients. Enough said…
What the heck does “Success” mean? What does a treatment success mean to you? I can tell you that from a research standpoint, defining success is very hard. As a result, a more honest and transparent way to report improvement is just to report metrics like pain, function, or percentage improvement (SANE score). For example, I recently saw data reported by the Cell Surgical Network, a group of doctors who use fat stem cells. First, there is no “n” listed, so we have no idea how many patients were treated. Next, a success metric reported for many different body parts treated is reported and is very, very high (close to 90%). However, this doesn’t match up with the pain scores, which drop over time but don’t seem to match up with such a high report of success. Meaning, the average person still has pain one to two years after the procedure. I wrote Dr. Mark Berman of CSN to get more details on what made up this success metric, but he refused to comment. So is this Rolex data or Smolex? Your guess is as good as mine.
How long are patients followed? How long would you like your relief to last after one treatment? Forever? Years? Most patients would tell me that they want relief somewhere between forever and years. Why then would you accept outcome information that only followed patients for a few months? How many treatments have you had, like a steroid shot, that only lasted a few months? If we asked you at month three, you would have said you were 90% better. Ask at month four, and you’re no better at all. Hence, the amount of time that patients are followed to produce outcome information is critical. They should be followed between forever and years! In fact, right now, for common orthopedic stem cell treatments, only Regenexx has that data. We’ve been tracking our patient results for almost a decade and a half. Everyone else? Nope, doesn’t exist.
Do these outcomes apply to this therapy? This would seem like a simple thing, right? You need to make sure that the therapy that’s being advertised is the same one that the graphs and charts talk about. However, there is often a bait and switch. Take for example a clinic calling itself Innovacyte. Like many others, they used two Regenexx published studies and placed them on their website as “proof” that their procedure worked. However, they don’t use our patented and proprietary lab processing or procedures to treat patients. Hence, this is a bait and switch.
What are the follow-up rates? Following patients for a long time is hard. Meaning, while a patient might eagerly fill out outcome forms for the first six months to a year, by year two they often say “enough already”! Hence, they drop off the map. Hence, normal registry follow-up rates (where you actively track patients) are about 60%. Meaning, you have data on about 60% of the patients you began to treat. So you don’t want much less than this, but the opposite is also a problem. Take, for example, a fat stem cell study that purported to show that it had a follow-up rate in the high 90s on more than a thousand patients. I knew immediately that this was almost impossible; hence, it caused me to dig deeper. Turns out that most of the data wasn’t patient reported, but reported by the doctor (i.e., the doctor’s perception of how the patients did rather than the patients’ opinion of the results). Mystery solved. However, the quality of doctor-reported data is questionable, so the study results can’t be used or compared to anything that patients reported.
What was treated? While this would also seem like a simple thing, it’s often something that’s not reported in outcome data. Take, for example, the data reported by the BioRenew PTM Therapy mentioned above. They reported that the 11 patients I discussed had “knee, hip, shoulder, and wrist arthritis.” So how many patients had knee arthritis? Unknown. How many had hip arthritis? Your guess is as good as mine. Shoulder or wrist arthritis? No idea. You see the issue, right? If you have hip arthritis and only one hip patient was treated that would be different than if eight were treated. At Regenexx, you can always find out how many patients we’re discussing. For example, right now for the hip, that would be 1,234 patients in our database. For knee, it’s 5,527.
How severe are the patients’ issues? What I mean here is that all orthopedic problems can be anywhere from mild to severe. Take, for example, hip arthritis. Our extensive data collection and analysis show that more-severe hip arthritis doesn’t do as well with a same-day stem cell treatment compared to mild or moderate hip arthritis. However, mild and severe knee arthritis respond the same. Hence, the data for mild hip arthritis patients would look very different from that for severe arthritis. So knowing the severity of the patients treated is important, as you want to make sure that the data they’re showing represents the severity of your problem.
Who is excluded and included? You can always make your outcome data look better by finding reasons to exclude the patients who didn’t do well. So you need to make sure all of the patients treated are included. This is what we do with all of our live outcome information.
The upshot? It’s very important that you educate yourself about the information you see, especially if that’s outcome data reported by a stem cell clinic. Hopefully, you’re a little smarter now and able to identify a Smolex, or to give credit where it’s due and find that rare Rolex out there!
About the Author
Christopher J. Centeno, M.D. is an international expert and specialist in regenerative medicine and the clinical use of mesenchymal stem cells in orthopedics. He is board certified in physical medicine as well as rehabilitation and in pain management through The American Board of Physical Medicine and Rehabilitation.…