According to a report in the Proceedings of the National Academy of Sciences, the rate of knee osteoarthritis has more than doubled since 1940, from 6% to 16%. Yet treatment options are limited when it comes to durability and effectiveness. Pain management and total knee replacements (TKR) have served as traditional patient options with more than 966,000 knee replacement surgeries performed in the U.S. every year. Now, various therapies are being investigated that may usher in a new era of regenerative medicine distinct from palliative pain management or surgery to close the treatment gap.
Promising Phase IIb Results
Last year the American Journal of Sports Medicine published results from an FDA-compliant, randomized, placebo-controlled Phase IIb trial sponsored by GID BIO. The trial evaluated adult patients with symptomatic knee osteoarthritis. Data showed that patients who received the cell therapy experienced a median 89% improvement in combined pain, stiffness, and function at one year compared to no improvement at one year for a control group who received a placebo. Through a two-year endpoint, no serious adverse events or serious device-related adverse events were reported.
Source: GID BIO (2020, February 28)
All study trial endpoints were met. “The Phase IIb results signified real science and a breakthrough in regenerative medicine,” said principal investigator for the Phase III trial, Jaime R. Garza, MD, DDS, FACS, Professor of Orthopedic Surgery and Center for Stem Cell Research and Regenerative Medicine at Tulane University School of Medicine and clinical professor of plastic surgery and otolaryngology at the University of Texas Health Science Center.
Evaluating Cell Therapy in a Pivotal/Phase III Clinical Trial
The next step in the FDA approval process is a pivotal/Phase III trial for which GID has actively begun enrolling and treating patients. The trial is intended to test the clinical efficacy and safety of GID’s device and its cellular output using patient-reported outcomes for pain and function. Patients are randomly assigned in this controlled and blinded clinical trial and receive either the cellular therapy injection or a placebo injection.
Future Considerations for Osteoarthritis Treatment
“Our treatment could have a significant impact in terms of decreased patient suffering and associated societal impacts. A durable therapy for knee osteoarthritis would transform the treatment for this serious condition due to rapid recovery time, reduced patient pain and less cost,” said Dale Tomrdle, vice president of finance and operations for GID BIO.