Tulane University School of Medicine announces pivotal / Phase III 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 / Phase III 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 anesthetic.
- 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.
“Eighty-eight percent of subjects responded greater than placebo at one year and reported a median 87% improvement in pain, stiffness and function,” said William W. Cimino, Ph.D., CEO of GID BIO. “We are able to isolate and concentrate the right types, number and viability of cells to create an effective therapy.”
Tulane University School of Medicine will be the first Phase III 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.
The free study is looking to enroll healthy men and women 35- to 85- years old with knee inflammation and a body mass index of 22 to 37. All participants will be compensated with MRIs, treatment, screenings and blood work included.
Call Louisiana Clinical Trial Center at Tulane at 504.988.0200.