Adam Anz, MD, is an orthopedic surgeon and sports medicine specialist at Gulf Breeze, Fla.-based Andrews Institute for Orthopaedics & Sports Medicine.
Serving as director of the Andrews Institute Regenerative Medicine Center, Dr. Anz oversees the ATC Fellowship Program at the Andrews Research & Education Foundation, where he is also a board member.
Here, Dr. Anz discusses regenerative medicine in orthopedics and what clinical trials excite him in the field.
Question: I understand you were recently involved in a clinical trial attempting to regenerate knee cartilage with patient's own blood stem cells. Can you share any details about the results of this trial?
Dr. Adam Anz: That study utilized mobilized cells to augment an arthroscopic procedure. We were using multiple stem cell injections to improve arthroscopic cartilage repair. It was a Phase 2b trial with the FDA and had an IED. We just closed it because we saw a statistically significant factor involving half of these individuals. It was an exciting result. The clinical research organization recommended we stop because we achieved statistical significance. So, our next step is to ask the FDA what they would like us to do for a pivotal final trial.
This whole process is kind of like building pyramids. You got to start with animal studies, design small trials to see if it's safe, then marginally bigger trials to see if it works and final large trials to see if it's reproducible. But once you have that body of work, you'll have clear evidence that it helps people.
Q: Do you see stem-cell based therapies making significant breakthroughs in orthopedics in the future?
AZ: We don't know exactly where we're heading with this. To me they're more tools in our toolbox. They're not going to be miracle cures. They're going to be real tools but there's going to be limitations to what they can do — limitations for the indications and maybe on the contraindications. Our goal is always to restore tissue and stem cells are going to help with that. They are probably going to help our athletes recover quicker but in terms of having some realistic expectations I think that's where we are in this curve.
In the progress of these therapies, you'll see a spike in early adapters as people become very encouraged but then you'll see it drop off a bit. I think we're on the back end of this bubble bursting and people are realizing that there's more we have to study and figure out. It's going to take a while to sift through.
Q: What do you see as the most effective regenerative medicine treatments on the market now?
AZ: At this point, I think you just have to ask what has the largest body of work and what does that body of work support. Right now, platelet-rich plasma has the body of work to support its use for osteoarthritis. Bone marrow aspirate is something that physicians have been utilizing. BMA has more cells than PRP and should work better, but it hasn't performed better in head-to-head clinical trials. So there's a body of work to support PRP right now but everything else has some work to do to prove they have value for our patients.
Q: What do you make of practices pivoting toward using these treatments without having that clinical body of work?
AZ: I think that some people take advantage of situations. There's a lot of hype and hope in this space right now but I think that we need to be deliberate. We have to be excited and push progress but at the same time we always need to put patient care first. We have to do our due diligence and prove safety and efficacy before we start marketing and making claims.
We need to start turning on our brain and ask what it means to develop a technology. What does it mean to bring that technology from the bench to the bedside? We can't stick our head in the sand and not understand translational medicine. We have to understand it if we're going to participate in it.
Q: Are there any clinical trials that you're currently excited about?
AZ: Absolutely, we've got one called the Bio ACL where we're trying to improve ligamentization — basically when a bone graft transitions from a tendon into a ligament. That process is variable. We know it takes time and we know during that process you have to be so safe with rehab. So we're seeing if we can track and expedite that with biology.
We concluded a clinical trial with our industry partner Arthrex about 18 months ago, which we're starting to get some data on. We're also working with Arthrex to design a follow-up — our second Bio ACL study. We're going to have to keep pulling different threads to see what works and see how far we can go with it.
Q: Is orthopedic research and innovation one of the primary things that drives you outside of your practice?
AZ: It is. It's fun to think about ideas and spitball with engineers and scientists. Now instead of bioengineers we're talking more to regular scientists — people who know a lot about cell biology. We've got a great research team and right now we're trying to find the best way to push this innovation forward.
The cell biologists know a lot about cell biology but they don't know a lot about what it means to drill a tunnel in a femur and put an ACL into it. It's all about working together. Collaboration and cross-colonization is what makes research work.