Biologics


 
Lyle Cain, MD and Jeff Dugas, MD
Treating damaged joints with the body’s own stem cells

“Heal thyself” is taking on a whole new meaning now that biologic therapies are rapidly emerging to treat a wide range of conditions.

In orthopedics, the surgeons of Birmingham’s Andrews Sports Medicine and Orthopaedic Center are among the more experienced trailblazers, testing and developing biologic therapies. Lyle Cain, MD, and Jeff Dugas, MD, are particularly interested in how biologics focus the body’s healing potential to rebuild cartilage and connective tissue in damaged and arthritic knees, shoulders and other joints.

“We started several years ago with platelet rich plasma (PRP) to treat ligament injuries and arthritis. The past two years, our primary area of investigation has been using autologous stem cells from the patient’s bone marrow to treat or slow the progression of osteoarthritis in the knee and to improve healing in revision rotator cuff surgery,” Cain said.

 “We’ve completed between 250 and 300 bone marrow aspirate, or BMA procedures. We still have to compile the data before evaluating it. However, from what I’ve seen so far in early follow-ups and at the one-year mark, I’m enthusiastic about how well patients are responding. Anecdotally, I’ve seen patients in their 50s who were walking with a cane return to running. A rare few patients— very few—haven’t reported a noticeable improvement. However, most tell me they have less pain and better function since the procedure.”

Dugas said most of his patients are telling him the same thing.

“We originally were aiming this toward younger patients to help them postpone the need for a knee replacement, but I’m seeing even older patients with more advanced osteoarthritis improving more than might be expected,” Dugas said. “Some wanted to avoid knee replacement surgery and decided to try the stem cell option instead. Most seem to be doing much better, and experiencing less pain.”

Stem cells can reproduce and differentiate, becoming cartilage, bone or other cells as needed. They also release growth factors and other cell signaling molecules that attract the body’s other healing chemicals to the site. These capabilities make them especially helpful in rotator cuff revision surgeries.

“Rotator cuff revisions have a very high failure rate because there simply isn’t enough tissue left to properly attach the structures or help with healing,” Cain said. “When we inject stem cells at the site, they start growing new cells to strengthen the attachment and to attract growth factors, anti-inflammatories and other biochemical support to accelerate healing.“A French study did a 10-year follow up that found 89 percent of revision rotator cuff surgeries with stem cell injections were still intact compared to only 40 percent of the same number of patients who did not receive the injections. That’s quite a difference in the long-term outcome,” Cain said.Dugas said, “Since the stem cells come from the patient’s own marrow and not a donor’s, the procedure fits within FDA guidelines. This reduces risk, and you don’t have the concern about triggering antibodies that might be a problem if the patient needs a transplant in the future.”At this point, aside from the limited number of orthopedic surgeons with experience in performing the procedure, the primary limitation to access is financial, since the new treatment isn’t covered by insurance.“We’ve been talking with major health insurers and they are interested in seeing more data,” Cain said.

“One of our primary goals is gathering solid evidence of outcomes. We want to learn who is and isn’t likely to benefit, the most effective techniques and what we can expect long term. In other areas of the country, out-of-pocket costs can be many times what we charge. We want to make biologic therapies as affordable as possible for patients, not only for their benefit, but also so we can do more procedures so we could gather enough data to be meaningful. We’re seeking answers we can rely on to advise our patients, and insurers can rely on to evaluate covering the procedure.BPA biologic therapy itself is simpler than the term “bone marrow,” might suggest. Rather than the more painful harvesting process used during the early days of bone marrow transplantation, the orthopedic version draws marrow from a more accessible site in the pelvis. Patients generally say they experience little, if any, pain.

“We harvest the bone marrow in an operating room so we can have an anesthesiologist to provide light anesthesia and sedation. It gives us a sterile working area where we have everything we might need immediately at hand,” Dugas said. “Using a specially designed kit, we draw off about 60 CCs of marrow, and then a centrifuge spins it down and separates the stem cells, so we have about 6 CCs to inject where it is needed.”

In addition to knees and rotator cuffs, the practice has also injected stem cells in hips. There is also interest in what stem cells might be able to do to regrow cartilage in painful backs, which is being investigated in other areas.Major research is being done around the world using stem cells to combat cardiovascular disease, diabetes, cancer and other diseases.

“It’s not for everyone, but for the right patient, it can be life changing,” Cain said. “We’re on the cusp of an exciting new time in medicine, and still early in the science of what biologics can do. In 10 to 15 years, I believe we will be speaking less about replacing joints and more about rebuilding and regenerating them.”

Dugas said, “I’d advise other physicians to keep a close watch on biologics. I tell them learning to manipulate cells for healing is like building a skyscraper. We’ve built the exterior and we’re now on about the second floor, but we have many more floors to finish and fill in as we learn what the body’s own healing potential can do.”

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Tags:
Andrews Sports Medicine and Orthopaedics. Lyle Cain MD, autologous stem cells, biologics, BMA, bone marrow, bone marrow aspirate, Jeff Dugas MD, knee replacement, osteoarthritis, platelet rich plasma, rotator cuff revision

 

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