Tulane University School of Medicine announces pivotal clinical trial for patients with knee osteoarthritis
The Tulane University Department of Orthopedics is testing a potential cellular therapy treatment for one of the world’s most common, disabling, painful musculoskeletal conditions, osteoarthritis.
In New Orleans WWL-TV announced the launch of a pivotal clinical trial to test the safety and efficacy of our point-of-care cellular therapy which intends to treat pain and function associated with knee osteoarthritis.
Participants in the clinical trial undergo an out-patient treatment performed in under two hours:
- A physician harvests a small amount of fat tissue from a patient’s abdominal or gluteal region under local anaesthetic.
- Using our SVF-2 technology, a patient’s own cells are isolated and concentrated into a cellular implant.
- The cellular implant is injected into the knee under ultrasound image guidance for precise placement and characterization.
The trial is a step in an FDA approval process which follows the publishing of data regarding our cellular therapy becoming the first one for osteoarthritis to meet study endpoints using autologous stromal cells from adipose tissue in a randomized, placebo-controlled clinical trial.
Tulane University School of Medicine will be the first pivotal site, conducted by the Tulane University Department of Orthopaedics with Dr. Jaime Garza as principal investigator. The former NFL player and Tulane University Athletic Hall of Fame inductee is a Professor of Orthopedics and Director of Human Regenerative Cell Trials at the Tulane University School of Medicine.