Professional athletes-turned physicians discuss the importance of cell therapy on The Ortho Show
Listen to former NFL players Jaime Garza, MD, DDS, FACS, one of GID BIO’s principal investigators, and Jim Kovach, MD, JD, as they reunite onThe Ortho Show, to discuss the treatment gap between pain management and major surgery and cell therapy’s potential to one day fill that gap.
The treatment gap is real. Patients use pain medications to temporarily manage their chronic condition in hopes of avoiding surgery. When those pain medications no longer offer relief, and patients can no longer tolerate the pain, there are no interim treatments available – major surgery is the only option.
As former college and professional athletes-turned physicians, Dr. Garza and Dr. Kovach are uniquely suited to discuss challenges and advancements in orthobiologics combined with their passion for cell therapy, “It’s a natural field for those of us who’ve played the game for so long,” said Dr. Garza.
Cellular therapy uses a cellular implant to attempt to treat or delay disease. Our Phase IIb study used patients’ own stromal vascular cells derived from adipose tissue to treat osteoarthritis of the knee.
Outcomes-based research is a fundamental component to ensuring the safety and efficacy of therapies that intend to treat conditions such as knee osteoarthritis. However, not all physicians comply with the regulations set by the Food and Drug Administration. The FDA issued a consumer warning in June about unapproved regenerative medicine treatments.
“These doctors are involved in a randomized, controlled trial for pre-market approval which is that arduous FDA process,” said Dr. Scott Sigman, MD and host of The Ortho Show, drawing attention to the stringent FDA approval process. Dr. Garza leads two of the Phase III trial sites at Tulane University School of Medicine and Texas Center for Cell Therapy and Research in San Antonio, and Dr. Kovach serves as Executive Director, Entrepreneurism and Innovation at the University of California Davis School of Medicine where the trial site is led by Charles De Mesa, DO, MPH.
For further information on the treatment gap and the potential of cell therapy, download our white paper.
Our investigational device is not for sale in the US and is being evaluated by the FDA as a Class III high-risk device.