Results from an FDA-approved multi-site, randomized, placebo-controlled Phase IIb clinical trial measuring the safety and efficacy of the SVF-2 device and point-of-care (POC) therapy intended to treat pain and function associated with knee osteoarthritis have been published in The American Journal of Sports Medicine.

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 2 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, according to a media release from GID BIO, manufacturer of the SVF-2 device.

“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,” 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, says in the release.

“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,” Garza adds.

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, per the release.

“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 1 year and reported a median 87% improvement in pain, stiffness, and function,” comments William W. Cimino, PhD, 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.”

[Source(s): GID BIO, PR Newswire]