Initial safety and feasibility of cellular therapy
Companies and clinics tout the promise of cellular therapy (usually as a “stem cell therapy”) backed by little more than anecdotal evidence and the hypothetical possibility of efficacy. When we launched GID BIO, we committed to ensuring that every device and procedure that bears our name is backed by sound medical research and clinically proven therapeutic results.
One of the first steps to ensure that a device and therapy is safe and effective is what’s called a ‘safety and feasibility study’. A safety and feasibility study is a research study designed to demonstrate initial product safety and the potential to be effective (feasibility) in the treatment of the condition for which it was developed.
GID BIO conducted two safety and feasibility studies on the treatment of osteoarthritis of the knee using the GID SVF-2 technology. The first study followed 6 patients (10 knees treated) that had moderate to severe OA pain for three months following the procedure. Results showed that there were no adverse events and that all subjects showed decreased pain in their knees1. The second study followed 6 patients (8 knees treated) with moderate to severe OA pain for one year. Results showed that there were no adverse events and that all subjects showed decreased pain in their knees2. Each of the patients in these two studies received a single autologous cellular implant of stromal and vascular cells—their own cells—delivered via precise injection, into one or both knees.
These two studies affirmed the initial safety and feasibility of our new technology and therapy for OA of the knee and provided the basis to proceed with a full evaluation of safety and efficacy in FDA compliant clinical trials. Once proven in the knee, we believe this technology has potential application to other osteoarthritic joints such as fingers and shoulders.
- Click here to read the complete study as published in Regenerative Medicine.
- Click here to read the complete study as published in the Aesthetic Surgery Journal.
1. Garza JR SMD, Palomera T, Dumanian GA, Dos-Anos S. Use of Autologous Adipose-derived Stromal Vascular Fraction to Treat Osteoarthritis of the Knee: A Feasibility and Safety study. Regen Med. 2015;4(1).
2. Fodor PB, Paulseth SG. Adipose Derived Stromal Cell (ADSC) Injections for Pain Management of Osteoarthritis in the Human Knee Joint. Aesthet Surg J. 2016;36(2):229-236.