"American Journal of Sports Medicine" publishes results of an FDA-approved clinical trial for treating osteoarthritis knee pain
LOUISVILLE, Colo. and NEW ORLEANS and SAN ANTONIO and CHICAGO, March 2, 2020 /PRNewswire/ -- GID BIO announced today that The American Journal of Sports Medicine published results of its FDA-approved multi-site, randomized, placebo-controlled Phase IIb clinical trial measuring the safety and efficacy of its SVF-2 device and point-of-care (POC) therapy intended to treat pain and function associated with knee osteoarthritis.
The Phase IIb clinical study was approved by the FDA under an IDE and is the first regenerative cell therapy for osteoarthritis to meet study endpoints using autologous stromal cells from adipose tissue. The cellular therapy for osteoarthritis procedure showed no serious adverse events at two years and a significant reduction in pain at one year. A Phase III pivotal study begins soon at Tulane University School of Medicine with additional trial sites participating nationwide.
"Publishing this data signifies real science and a breakthrough in regenerative medicine. We've completed a prior safety trial, an FDA-approved Phase IIb trial, and are now beginning a Phase III pivotal trial. Physicians will be able to use the SVF-2 technology to provide a cellular therapy option for patients," 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. "I am very proud to collaborate with my alma mater, Tulane University, and the School of Medicine's outstanding orthopedic department led by Dr. Felix Savoie, and its world–class Center for Stem Cell Research and Regenerative Medicine directed by expert cell scientist Dr. Bruce Bunnell," said Dr. Garza.
Dr. Garza is a former NFL player and a Tulane University Athletic Hall of Fame inductee. He is also a clinical professor of plastic surgery and otolaryngology at the University of Texas Health Science Center.
Treatments by clinics using stem cells are under scrutiny by the FDA as its discretionary enforcement period expires in November of this year. The intent is that hundreds of stem cell clinics nationwide become compliant with FDA regulations, leading to clinical data support of safety and efficacy.
"Our randomized, controlled clinical trial is the first cellular therapy study for osteoarthritis to meet study endpoints using autologous adipose stromal cells for a point-of-care therapy. 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 and numbers of cells to create an effective therapy. We are pleased to begin Phase III trials with Dr. Garza, and to be at the forefront for a cellular therapy option for osteoarthritic knees."
About GID SVF-2 and POC Therapy
GID technology has reduced a Good Manufacturing Practice (GMP) cell-processing facility to a single-use disposable device for scalable point-of-care cell processing. The technology uniquely harvests and isolates stromal cells from a patient's own adipose tissue that is then reimplanted by injection in a physician's office in less than two hours. Stromal cells play an essential role in the body's natural healing response, with a dynamic and reactive ability to participate in the healing process. The American Medical Association granted GID two new CPT class III codes that became effective January 2020 as a step toward Medicare reimbursement.
About GID BIO
GID BIO develops next-generation cellular therapies for degenerative musculoskeletal, dermal, and organ-specific diseases, with the goal of making cellular medicine available to as many people as possible. GID's SVF-2 device and POC therapy harnesses the innate healing power of a patient's own stromal cells. Information on GID's SVF-2 device, biologic cellular implants, POC therapy, osteoarthritis clinical program and GID's pipeline for treating degenerative disease in musculoskeletal conditions includes other indications including, dermal and organs, specifically, wound care and diabetes. Learn more: https://www.HealingIntelligently.com.
About Tulane University School of Medicine
One of the nation's most recognized centers for medical education, Tulane University School of Medicine is a vibrant center for education, research and public service. Tulane School of Medicine is the second-oldest medical school in the Deep South and the 15th oldest medical school in the United States. Tulane School of Medicine recruits top faculty, researchers and students from around the world, and pushes the boundaries of medicine with groundbreaking medical research and surgical advances. Tulane remains in the forefront of modern medical innovation and is equipping the next generation of medical professionals with the tools to succeed in the rapidly changing future of health care.
About American Journal of Sports Medicine
A global organization with 3,000 members that generates evidence-based knowledge and promotes emerging research to educate orthopaedic surgeons and a resource for the orthopaedic sports medicine community, American Journal of Sports Medicine is a peer-reviewed scientific journal, first published in 1972. It is the official publication of AOSSM featuring 14 issues per year. The journal acts as an important forum for independent orthopaedic sports medicine research and education, allowing clinical practitioners the ability to make decisions based on sound scientific information.
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