Adam Anz, MD, of Gulf Breeze, Fla.-based Andrews Institute for Orthopaedic and Sports Medicine, is leading a randomized controlled trial attempting to regenerate knee cartilage with stem cells.
Dr. Anz, MD, is an orthopedic surgeon specializing in sports medicine and stem cell research at the Andrews Institute. He spoke with Becker's ASC Review about his and the Andrews Institute's work around regenerative medicine and the future of such treatments.
Dr. Anz is leading the U.S.-based portion of a randomized phase II clinical trial around a cartilage regeneration technology which utilizes mobilized hematopoietic stem cells. The trial originated in Malaysia and was developed by Khay-Yong Saw, MD, an orthopedic surgeon at the Kuala Lumpur, Malaysia-based Kuala Lumpur Sports Medicine Center. The trial started in May 2017 and is in the midst of a 24 to 36-month enrollment period. The FDA is carefully monitoring what would be a first-of-its-kind technology.
While many stem cell technologies are being developed with clinical trials underway, there is very little scientific evidence for some treatments offered by clinicians in the U.S. as “stem cell” treatments. Dr. Anz is afraid the medical community has "gotten ahead of our skis," in terms of regenerative medicine use. One such example concerns bone marrow aspirate and adipose products. Clinics around the U.S. have been using BMA and adipose derived products to treat osteoarthritis without clear evidence that the treatment is effective.
"As a whole country and community, we've gotten a little ahead of ourselves with bone marrow aspirate. Although we offer BMA, I'm using platelet rich plasma for knee arthritis because at this point, PRP has more evidence that it'll work for your knee arthritis. Whereas BMA may have a lot of hype, at this point it doesn't have a lot of evidence. … That's where we need to not get too far ahead of our skis but instead stay over our skis and do the research on it," Dr. Anz says.
In response to “a small number of unscrupulous actors,” the FDA has recently increased its actions regarding regenerative medicine. In August, it released a statement announcing its intentions to increase oversight and enforcement around the use of stem cell treatments and sent a warning letter to a Florida clinic that it was improperly marketing and performing stem cell treatments involving adipose. The regulatory agency also seized a live virus vaccine from a San Diego-based clinic after the agency found it was also improperly marketing treatments. In November, the FDA released two finalized guidance documents which clarified their position on how minimal manipulation and homologus use apply to regenerative medicine treatments, key principles in what treatments clinicians can offer their patients. The FDA’s intent is to protect the public’s health and pocketbook from treatments that have not proven themselves safe and effective.
Despite the publicity, Dr. Anz and the Andrews Institute are confident in the value of the treatment and the value stem cells hold for the orthopedics and sports medicine industries.
Dr. Anz says, "To me [regenerative medicine] does represent the types of technologies that'll be the next 30-year of development in sports medicine. We've gotten pretty good at what we do with the carpentry of sports medicine, but what we can really improve is the biology of what we do. Cells are at the center of that biology."
Dr. Anz believes regenerative medicine will be prevalent in the sports medicine market through the next 30 years. That said, he anticipates the market will need considerable time to adapt to the new treatments. He compared stem cells to the last big breakthrough in orthopedic sports medicine, the arthroscope. The arthroscope was introduced to the market in the late 1970s and it took 30 years for its adaptation to become firmly established.
"Similarly this is a new sentinel technology but it's going to take us 30 years to sort out exactly how to use it perfectly" Dr. Anz says. "And we're going to be advancing and developing all along the way. I'd say regenerative medicine is here. However, we really need to be good stewards of it, and we need to do our homework. The same way the pioneers of the arthroscope did."