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Melanie Cole: Over the past decade, there's been an increased interest in the use of biologic therapies in sports medicine. Welcome to UAB Med Cast. I'm Melanie Cole and today we're giving an update on the latest research and clinical implications for biologic injection therapies in sports medicine. Joining me is Dr. Amit Momaya. He's the Chief of Sports Medicine at UAB Medicine. Dr. Momaya, thank you so much for joining us. This is such a great topic. It's so interesting. Tell us how developments in regenerative medicine and treatments have advanced over the years? As we see this emerging problem of sports injuries, give us a little background.

Dr. Momaya: Sure. You know, there's been a lot of interest in what we call orthobiologic injections across multiple fields, but really sports medicine has come to the forefront of potential applications of, orthobiologic injections, especially when it comes to getting athletes and active individuals back to their lifestyle in a quicker manner. And also at times, potentially even avoiding surgeries, we've looked at various types of injections across years. And until recently we didn't have much data or research on them, but the field has grown tremendously and more and more people are becoming interested in them.

Host: Certainly true. I've heard so much more about them lately. So tell us about the most common overused joint conditions and tendinopathies that you're using these for? Tell us a little about the trends that are happening with biologic therapies.

Dr. Momaya: Some of the most common conditions that we use orthobiologics injections for include tennis elbow. Tennis elbow is a condition where of course you can have some tendinopathy of the lateral aspect of your elbow, often from repetitive activity in motion. You know, most people do not get it from actual tennis, but rather just repetitive activity and doing other things. It can hurt a lot, just picking up a purse or getting a milk jug out of the fridge. And traditionally we used to inject those with corticosteroids routinely and tried to, you know, various bracing and conservative physical therapy. And we had some mediocre results with those things. We weren't exactly sure if the steroid injection was doing much because as we understand further and further, that's actually not so much a inflammatory process that's happening in the lateral elbow tendons. It's actually perhaps a degenerative and lack of vascular problem in that area. So, one of the potential solutions that people have espoused is orthobiologics injections, specifically PRP, which stands for platelet rich plasma.

It's a, it's a pretty easy process overall where the patient has blood drawn from a peripheral vein in clinic. The blood is introduced into a syringe where it's placed into a centrifuge and spun down and the platelet rich aspect is collected. And so one of the applications we've seen is PRP injections into lateral elbow tendinopathy that has been somewhat of a game changer. It's helped tremendously. We've seen much better results with using PRP compared to steroid or other placebos, it's really helped us kind of on that specific pathology. In addition, we've also used it for knee arthritis, you know, knee arthritis is actually one of the conditions that probably have the greatest amount of research when it comes to biologic injections. In a similar fashion, like one would inject a steroid into the knee. We inject PRP into the knee and some of the benefits of that is that PRP, unlike steroids can help with potential healing process. But what we really think it does is it reduces inflammation and works on the pain pathway to decrease pain you felt in the knee. And so those are some potential applications that have had the most research involved with PRP.

Host: So glad you talked about that. And I was going to ask you what types we were talking about because there's also STEM cells. You know, we're hearing about different kinds. So speak a little bit about any research based evidences you have for optimal decision making. When you're looking at which one you want to choose, are there best practices among people in your field? You know, how is that decision going on between PRP and MSCs and these kinds of things?

Dr. Momaya: A lot of debate about what most effective, what works the best and there's research to support various things. So taking a bird's eye view, like you said, there's PRP in addition, there is a kind of vague term called STEM cells. And within medicine, we do know that those formulations don't have many STEM cells at all actually. People prefer medicinal signaling cells or mesenchymal stromal cells. Those are probably more appropriate terms is because we think these are just cells that signal a cascade of events that occur in the joint or the tendon for healing purposes or anti-inflammatory purposes. And so well, let's talk about the actual STEM cells, most common, what people talk about is a bone marrow aspiration concentrate injection, or BMAC for short. And that's where a needle is inserted into most commonly the pelvic rim. And then from the pelvic bone, you draw from the bone marrow blood, which is thought to have a high concentration of those municipal signaling cells.

And that's what's actually prepared and injected into the knee or into a tendon that needs healing. You know, there's some good research that can also help pain in the knee from arthritis or tendinopathies, but probably the most number of studies we have is actually still focused on PRP. Another potential application or rather solution of orthobiologics, as we get into the product of amniotic products. So amniotic tissue, as we all know, it can be a potential source of very rich number of pluripotency cells. And specifically people have espoused the use of allograft tissue that is sometimes freeze dried to inject those formulations so those are kind of somewhat prepared. They come in powder solutions oftentimes, and you can mix them with saline and inject. Those types of applications involve knee arthritis and tendinopathies also. So kind of to summarize, you know, looking at a bird's eye picture, we're talking about PRP, bone marrow aspirate concentrate or STEM cells, and also amniotic allograft tissue.

Host: That's so interesting. And I'm so glad that you mentioned that the term STEM cell has been overused. Now, Dr. Momaya, do you have a concern that misinformation from direct to consumer marketing of largely unproven biologic treatments might erode public trust, and since there's been controversies over some of the use of these since professional athletes and have traveled abroad to receive some of these therapeutic procedures. Do you have concerns that this unmonitored practice with regard to risk exposure, you know, as well as exposure to adjuvants of substances that may come into play here, have you been seeing this at all in your practice with athletes?

Dr. Momaya: Yes. I'm glad you brought that up. That's a big concern. You know, I think these formulations have been marketed not only by health professionals, but by other people that are like, or maybe loosely affiliated with the field that may not have the quite the training that doctors may have and have, you know, erected these STEM cell clinics that are run by people who are not necessarily board certified sports medicine providers, and these clinics often take cash pay for these injections. And they may say that, you know, we can provide you a great better lead for your arthritis or other various diseases. And sometimes they don't have any proof furthermore, these can lead to sometimes complications. You know, there's been articles in the news about infections involving the spine involving the eye. So very serious infections from injections that have not been monitored. Luckily the FDA has come down hard on some of these clinics and there's much more oversight over the past years then there's been in the previous decade on these types of clinics.

You know, we actually did a study here at UAB looking at just the cost of variability. You know, a lot of times people ask me, are these injections covered by insurance? And the general answer is no, these injections, these biologic injections are still thought to be experimental and further data is needed. So they're not covered by insurance. And so one of the things that, you know, my research team at UAB, we looked into the cost variability just to see what kind of variability there is to give an idea of how many market factors are coming into play. Specifically in PRP, we found a range when we looked all over the country, we found a range from anywhere from $175 for the injection up to $5,000. What's more astounding is for STEM cells, quote STEM cells. We found a range from $300 up to $12,000. As you can imagine, this varies based on geographic location and the average income in that zip code, but you know, anything that has a price variability of that much, you're starting to get a little bit concerned, right. You know, are these all the same products? Is it really working? You know, what are we actually selling with such variability in pricing?

Host: So interesting Doctor that you say that, and in my research, I saw some of that. So is there an effective biologics registry? What would that require in your studies, have you looked into a registry?

Dr. Momaya: Yeah, so, you know, our American Academy of Orthopedic Surgeons, there's a task force involved in establishing a good solid registry with people who use biologics, following the outcomes and seeing what actually works and what doesn't. Because right now, like you said, it's kind of the wild, wild West it's, whoever wants to, whoever wants to inject them and collect the cash and people want to pay for them, and people are going to these STEM cell clinics and no data's being collected on the efficacy of these things. So we need more studies and there have been randomized controlled trials, but it's just the beginning. We need greater numbers. And so that's where these registries come into play. And I think over the next five to 10 years, you're going to see a large amount of literature published out of these registries to really tell us what works, what doesn't work. But until then, I think, like you said, athletes sometimes go abroad to get the newest and latest treatments from Europe and other countries, other areas. And so a lot of the athletes in the US and a lot of the younger people in that kind of the weekend warrior, they also see that as a, you know, I want the latest and greatest, even though the research may not have caught up yet.

Host: That certainly is true. And how have been your outcomes? What about patient reported outcomes? Tell us what you've seen and how it works.

Dr. Momaya: Kind of going back to what we initially discussed, you know, the number one utility of a biologic injection. My clinic currently is knee arthritis, and we've seen some good outcomes. We followed our patients thus far looking at mild to moderate knee arthritis and the use of PRP, platelet rich plasma, and we've seen some pretty good results. And one of the benefits of PRP is that it is not condor toxic from what we know of. You know, if you inject a steroid into a knee, it is condor toxic. The more steroids you inject into the knee. It's probably a dose dependent relationship and can really increase the condor toxicity and hasten sometimes the arthritis. So that's a great advantage of using PRP not only in older adults, but especially in younger adults, athletes who are active, we don't want to be injecting them full of steroids. So that's an important concept to know, is that, so we've seen great results from PRP when it comes to knee arthritis and also tennis elbow.

That's one of the most common things, tennis elbow, or any kind of tendinopathy, whether it be patellar, tendinopathy, Achilles tendinopathy, we've used PRP. Now an important note is that what I always recommend for patients, is they go to a clinic that has a board certified sports medicine physician there. And the reason that's important is because there's actually different formulations of PRP. And one of the big kind of dividers between PRP is whether you're talking about leukocyte rich or leukocyte poor. So essentially, you know, what's the concentrate of white blood cells in that? And some of the initial research, what we found is when you're injecting into a tendon that you want to vascular response into, we're typically recommending a leukocyte rich injection. This is in contrast to a joint where you actually may want a leukocyte poor. You actually may not want any type of anabolic cascade or anything that causes too much of a response in a knee, it may flare up too much. And so we usually lose, use a leukocyte poor concentrate in the knee or hip or ankle, wherever you're injecting into a joint where there's cartilage.

Host: As we wrap up this very interesting topic Dr. Momaya, tell other providers and referring physicians what you want them to know based on everything we've said here today, about regenerative medicine, regenerative strategies, and what you're doing there at UAB.

Dr. Momaya: In summary, I think orthobiologics and regenerative medicine are here to stay. It's going to be a forefront of our specialty over the next few decades. But the most important thing I think is to educate the patient on the limitations of what it can do right now. And to emphasize that we're typically not regenerating. We're not regenerating cartilage. Usually we're not regenerating cells to be able to cure your knee arthritis. These are still treatments that are largely symptomatic treatments, rather than a cure curative process. I hope one day we will get there. We're at a point where we can regrow cartilage reliably with injections in the clinic, and that would change the face of the treatment of arthritis. But right now, these biologic injections are still symptomatic. And that UAB, what we're trying to do is follow the outcomes of these patients who received these biologic injections to first make sure they work, and then to work with our basic science colleagues and see how we can change the change, the formulations, where we can start getting into the realm of let's start growing these cells and finding cures for arthritis.

Host: Great information. Thank you so much Doctor for joining us today. A community physician can refer a patient to UAB Medicine by calling the MIST line at 1-800-UAB-MIST. And that wraps up this episode of UAB Med Cast. For more on resources available at UAB Medicine. Please head to our website at UABmedicine.org/physician. Please also remember to subscribe, rate, and review this podcast and all the other UAB podcasts. I'm Melanie Cole.