Trial measures safety and efficacy of device and point-of-care cellular therapy to help reduce pain and improve function in osteoarthritic knees
Louisville, Colo. and Chicago, Ill. – January 30, 2020 – GID BIO announced the acceptance by the American Journal of Sports Medicine to publish results next month of an 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.
In a major development, the study was approved by the FDA under IDE and is the first regenerative cell therapy to meet endpoints using autologous stromal cells from adipose tissue. Trial results showed significant reduction in pain and no serious or device-related adverse events after two years.
“This study demonstrated that results for the treatment groups were statistically significant relative to a placebo control,” said William W. Cimino, Ph.D., CEO of GID BIO. “This study of our SVF-2 device and POC therapy showed that 88% of subjects responded greater than placebo at one year and reported a median 87% improvement in pain, stiffness and function. With conditional approval from the FDA, a larger pivotal/Phase III study begins soon.”
After harvest, the GID technology precisely isolates and concentrates stromal cells from a small amount of the patient’s adipose tissue. This process followed by the cellular implant is completed in a physician’s office in less than two hours.
“Scientifically proven cellular transplants using the patients’ own stromal cells, verified through FDA-approved clinical trials, are a breakthrough in regenerative medicine. The GID system utilizing the SVF-2 device should be the treatment of choice. Anyone treating osteoarthritis of the knee needs to prepare for the future by learning this procedure as a way to provide more options for patients. Delaying participation in the orthobiologics movement, similar to cardiothoracic surgeons 25 years ago not learning how to stent vessels to treat heart disease, can prevent orthopedic patients from benefiting from these new and proven therapies.
Minimally invasive is now a standard,” said Jaime R. Garza, MD, DDS, FACS, principal investigator for the pivotal/Phase III trial, president of Texas Center for Cell Therapy and Regenerative Medicine at Texas Center for Athletes and professor of orthopedic surgery, Center for Stem Cell Research and Regenerative Medicine at Tulane University School of Medicine.
The SVF-2 technology reduces a Good Manufacturing Practice cell-processing facility to a single, disposable device for scalable point-of-care cell processing. Stromal cells play an essential role in the body’s natural healing response, which is different than a drug that is a synthetic chemical compound with no dynamic or reactive ability to participate in the healing process.
“There is potential for GID’s device and therapy to be a tremendous benefit to patients,” claimed Bruce Bunnell, Ph.D., professor, director of the Center for Stem Cell Research and Regenerative Medicine at Tulane University School of Medicine. “The right types of healing cells are extracted to control inflammation in patients with osteoarthritis. These cells work better than any other cells or drug currently available. Once FDA-approved and widely available, most patients will likely want to use their own healing cells rather than other drugs or surgical options.”
About GID SVF-2 and POC Therapy
GID technology has reduced a Good Manufacturing Practice (GMP) cell-processing facility to a single-use 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 under ultrasound guidance. The American Medical Association granted GID two new CPT class III codes that will become effective January 2020, 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 pipeline can be found at: https://www.HealingIntelligently.com.
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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