Existing alternatives to manage pain for patients with knee osteoarthritis include hyaluronic acid (HA) injections or corticosteroid (CS) injections which may be toxic to cartilage according to a Radiology report. Chris Schenk, a San Antonio realtor and avid tennis player, tried an HA injection which she said helped reduce her knee pain for only one week.
Experts say there are more than four million HA and CS injections and nearly one million total knee replacement surgeries performed annually. These procedures cost billions, a number ripe for relief in an already taxed U.S. healthcare system.
GID BIO has developed a new potential treatment option, a single-use device and cellular therapy, that can be performed by trained physicians in multiple specialties including sports, pain, orthopedics, and interventional medicine. It works by: 1) taking a small-tissue harvest (30 ccs) of adipose tissue from a patient’s abdomen or gluteal region, 2) isolating stromal vascular fraction cells from that harvest, and 3) reimplanting those cells into a patient’s knee at point-of-care.
The procedure is expected to be significantly less costly than a TKR and prioritize a patient’s quality of life.
“If your therapy is trying to stop degeneration and help restore balance to the unhealthy environment causing cartilage degeneration, than adipose (tissue) is the way to go,” says Dr. Diego Correa, an assistant professor at the University of Miami’s Miller School of Medicine, researcher of adult stem cell biology and keynote speaker at the Interventional Orthobiologics Foundation 2020 symposium.
GID’s therapy is the first cell therapy for osteoarthritis to meet study endpoints using autologous stromal cells from adipose tissue, in an FDA-approved, multi-site, randomized, placebo-controlled Phase IIb clinical trial. A Phase III trial is starting soon placing GID on track to provide the first potential FDA-approved therapeutic option for osteoarthritic knees.
“GID BIO is years ahead of others trying to develop similar therapies in terms of data and results,” says Gerard Malanga, founder of New Jersey Sports Medicine, LLC, and president of Interventional Orthobiologics Foundation.
GID has ongoing studies applying cellular therapy to additional degenerative diseases including those of the respiratory system.
“We are exploring the application of our scalable technology platform for respiratory conditions like COPD,” said William Cimino, CEO of GID BIO. “Our goal is to make cellular medicine available to millions by addressing multiple degenerative disease states.”