Legions of professional athletes have sought restorative medicine treatments for injuries to tendons, ligaments, cartilage, knees, hips, and backs, including such high-profile athletes as golfer Tiger Woods, basketball legend Kobe Bryant, Yankees player Alex Rodriquez, and tennis great Rafael Nadal.
In orthopedic sports medicine, the promise of regenerative medicine—or, the more accurate term, restorative medicine--is to accelerate healing and to decrease scar formation, adhesions, pain, and inflammation at the site of injury or surgical repair. (We can’t yet regenerate damaged tissues and joints or make them normal again. Rather, we’re creating a more favorable healing environment.) Faster and better healing limits muscle atrophy, allows for early weight bearing, and reestablishes range of motion, improving overall function and considerably shortening the amount of time an injured athlete is sidelined. While not yet substantiated, this evolving area of medicine may improve long-term outcomes as well.
Inspired by stories of the pros’ remarkable recoveries, collegiate, high school, and weekend athletes are also seeking restorative medicine therapies. These biologics are not just beneficial for athletes; there is a growing interest among those older individuals with arthritis – seeking an alternative to joint replacement for their activity related pain.
Restorative medicine is poised to grow. The global restorative medicine market is projected to reach $48.90 billion by 2021 from $17.20 billion in 2016, growing at a compound annual growth rate of 23.24% from 2016 to 2021.
Entrepreneurs have seized on that high-growth potential by starting independent restorative medicine clinics—and that worries me. Many of these freestanding regenerative medicine clinics are simply capitalizing on patient demand and are making claims unsupported by scientific evidence that commercially available biologics can cure degenerative osteoarthritis. As a physician, I’m concerned about the safety and efficacy of biologics administered by clinics more interested in reeling in self-paying patients willing to spend thousands of dollars on a treatment than in offering restorative medicine therapies that are truly effective. I see a big opportunity—and even a responsibility--for hospitals to offer regenerative medicine therapies that are safe and based on clinical evidence, not solely on marketing claims.
A major role for hospitals
Restorative medicine are biologic products that can repair, restore, or regenerate cells, tissues, or organs that are not functioning as they should due to injury, disease, aging processes, congenital defects, and trauma. Currently they are used most frequently in orthopedic applications for the treatment of soft tissue or cartilage conditions including meniscal repairs, reconstruction of ligaments or cartilage, and to treat plantar fasciitis, tennis elbow, and other inflammatory conditions. However, restorative-medicine therapies have also successfully treated diseases of the eye, chronic diabetic leg and foot ulcers, and burns for some time.
In orthopedics sports medicine, primary restorative medicine therapies include platelet-rich plasma (PRP), bone marrow aspirate concentrate (BMAC), adipose-derived mesencymal stem cells, and human amniotic membrane (AM)-derived tissues. These therapies take very different approaches while seeking to accomplish similar objectives. They are also procured in different manners, and in a variety of venues.
Therein lies the problem. Some of these biologics work very well and have the scientific evidence to support them. For example, human amniotic membrane-derived tissues, with their unique, anti-inflammatory characteristics, have a lengthy and well-documented track record of clinical success and safety. They’ve been used since 1997 to heal ocular injuries and are now the advanced therapy of choice for the treatment of difficult-to-heal chronic wounds. Other regenerative medicine therapies either lack scientific and clinical evidence demonstrating their effectiveness, or their efficacy claims are based on poorly designed studies.
The source of the biologic product can also impact efficacy. Amniotic membrane tissues are procured only following healthy, full-term live births and are processed using standardized, reproducible methods, yielding consistent clinical benefits. However, some have only amniotic tissue while others include the much more advantageous umbilical cord component. Autologous restorative medicine products, on the other hand, can vary considerably in quality, based on the overall health of the patient and the clinician’s technique for harvesting, processing, and transferring the autologous stem cells, platelets, and growth factors back to the patient.
Unfortunately, too many independent restorative-medicine clinics let economics guide their treatment decisions, jacking up the price of a single PRP injection to $2,000, for example. Even worse are those clinics that push completely useless—or even harmful treatments, i.e. ozone — injections to a joint.
A patient would have a completely different restorative-medicine experience in an outpatient clinic associated with a hospital. The protocols and culture of a hospital demand that clinical safety and evidence-based medicine govern any procedure offered to patients. A patient who gets a restorative medicine therapy at a hospital clinic knows that the biologic has been acquired through a legitimate supply chain, that the product meets quality standards and has not expired, and that the procedure will be done in a sterile environment.
A hospital clinic also offers patients the assurance that a physician is choosing the most appropriate biologics to treat a specific injury--not injecting the most costly product in order to pad an entrepreneur’s pocket. Hospitals stand behind their medical therapies, following patients to ensure there are no untoward side effects, while collecting data and doing prospective studies to determine which patients have the best outcomes from different types of restorative medicine therapies.
A hospital that offers restorative medicine in conjunction with its sports medicine services has an opportunity to differentiate itself from the independent clinics by promoting its high standards, safety, and institutional rigor. Restorative medicine is here to stay, and hospitals will miss out on this exciting new field—and a steady stream of patients—if they sit on the sidelines, because their patients refuse to do the same.
The top priority for me and my patients is to achieve the best functional outcomes from surgical and nonsurgical treatment. Biologics may certainly help us accomplish that by improving the healing environment and achieving a higher quality repair of tendons, ligaments, and cartilage. Clinicians have an obligation to their patients, who often spend thousands of dollars on restorative-medicine treatments, to vet the products in this emerging field and guide them to modalities that offer biological value—and hospitals are ideal partners in this endeavor.
Dr. Robert Anderson is a member of the Green Bay Packers’ medical team and a partner at Bellin Health Titletown Sports Medicine and Orthopedics in Green Bay, Wisconsin. Formerly the chief of foot and ankle surgery at OrthoCarolina/Carolinas Medical Center in Charlotte, North Carolina, Anderson retains a part-time practice there. He is also the co-chair of the NFL Musculoskeletal Committee and a consultant to numerous professional and collegiate teams.