A first-of-its kind meeting brought leaders from eight orthopedic, sports medicine, pain management and regenerative medicine advocacy organizations together to discuss advancing cellular medicine in the U.S.
The group of physicians, lawyers, engineers, PhDs, and CEOs from American Medical Society for Sports Medicine, Arthritis Foundation, Arthritis National Research Foundation, BoneSmart, Interventional Orthopedics Foundation, Regenerative Medicine Foundation and Regenerative Outcomes, realized the potential of combining forces to address:
- evidence-based data, FDA compliance and industry guidelines
- building a consistent voice with collaboration to combat ‘bad actors’
- the development of a healthy dialogue among physicians as orthopedics evolves to include interventional – or minimally invasive – orthobiologic procedures
- a national registry of data to help prioritize patient quality of life initiatives and reported outcomes
- initiatives that help relieve a $200 billion osteoarthritis burden on the US healthcare system
- an ecosystem that supports a nationwide workforce development for cellular therapies
Major developments in cellular medicine options for patients suffering from pain associated with knee osteoarthritis (OA) must show safety and efficacy. GID BIO is the only company to meet all endpoints for an adipose-derived cellular implant in a multi-site, randomized, placebo-controlled Phase IIb clinical trial. Results from the trial, testing the safety and efficacy of GID BIO’s SVF-2 device and point-of-care cellular therapy, show 88% of treated subjects responded greater than placebo and reported a median 87% improvement in pain, stiffness and function at one year and no serious or device-related adverse events at two years.
These results, when shared, help separate good actors from bad actors and emphasize the FDA’s role in shaping the narrative as the industry continues to move forward.
“How can we separate the signal from the noise and shift the landscape of communications from bad to good?” asked GID BIO CEO, William Cimino, Ph.D.
A consortium of leaders representing evidence-based cellular medicine that promotes broad access to these therapies is one answer. “The goal is to get safe and effective treatments to as many people as possible. GID BIO’s SVF-2 device and therapy, because it is point-of-care, could help achieve that goal,” noted Doug Oliver, CEO of Regenerative Outcomes.
An aligned industry of good actors, physician interest and a qualified workforce is next. As Scott Bruder, M.D., Ph.D. claimed, “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.”
Shaping a workforce ecosystem that garners health systems’ support of minimally invasive OA treatment options, clinical guidelines and a CME curriculum, could fundamentally shift the treatment of pain and function associated with knee osteoarthritis and help address a $200 billion burden on the US healthcare system.