Over the past three decades cardiothoracic procedures have significantly shifted to minimally invasive techniques with new technology, training of physicians and an ecosystem for workforce development.
Orthopedics is on the forefront of a similar shift. Fourteen million U.S. adults suffer from knee osteoarthritis and professional athletes are driving a demand for alternative treatments to surgery, despite many being unsupported by data and lacking proof of success.
This level of patient demand and a frenzy of companies offering unproven therapies, calls for a generation of physicians properly trained. “We must educate our physician customers in not only the basic and clinical science, but the regulatory framework for proper product promotion and use. In this way, we can effectively manage the expectations of patients, deliver high quality care and allow the high tide of success to raise all well-constructed boats that venture into these turbulent waters,” says Scott Bruder, MD, PhD.250
Physician education starts with data-driven, evidence-based therapies for treatment and the building of a workforce development to support a new industry. GID BIO’s SVF-2 device and point-of-care (POC) therapy is a possible example after meeting endpoints in a randomized, controlled Phase IIb clinical trial and being recently granted conditional approval from the FDA for a pivotal study. “GID BIO is years ahead of others trying to develop similar therapies in terms of data and results,” says Dr. Gerard Malanga, founder of New Jersey Sports Medicine, LLC, and an invited expert at a recent collaborative industry roundtable discussion aimed at advancing cellular medicine.
Training would teach physicians how to perform the 120-minute procedure in steps:
- Extract a small amount of fat tissue from the patient’s abdominal or gluteal region under local anesthetic
- Harvest and isolate stromal progenitor cells from the extracted tissue using the SVF-2 technology
- Reimplant the cellular implant into the patient’s knee under ultrasound image guidance
Healthcare systems over the past several decades have been faced with learning the intricacies of increasingly popular minimally invasive cardiac treatments. Now healthcare systems everywhere are challenged to add cellular medicine departments to remain on the forefront of orthopedics like Tulane, University of Southern California, UPMC, UT Health San Antonio, and Carolina Institute for Clinical Research.
“Anyone treating osteoarthritis of the knee needs to prepare for the future by learning this [GID BIO’s] procedure as a way to provide more options for patients. Delaying participation in the orthobiologics movement, similar to cardiothoracic surgeons 25 years ago not learning how to stent vessels to treat heart disease, can prevent orthopedic patients from benefiting from these new and proven therapies. Minimally invasive is now a standard,” said Jaime R. Garza, MD, DDS, FACS, Professor of Orthopedic Surgery, Tulane Center for Stem Cell Research and Regenerative Medicine.
With a growing number of physicians sharing a goal of advancing evidence-based cellular medicine, as seen by American Academy of Orthopaedic Surgeons’ recent announcement to invest in orthobiologics, and growth of physician training with Interventional Orthopedics Foundation’s courses, an increasing ecosystem is helping to shift health systems’ support of minimally invasive OA treatment options, clinical guidelines and a CME curriculum that speak to the ability to provide better care and new therapies being developed.