San Diego-based regenerative medicine company Cytori Therapeutics, Inc. has just announced it will be hosting an information session on scleroderma, and a presentation of its key STAR clinical trial. Lead investigator on the STAR trial, Dr. Dinesh Khanna, will be conducting the discussion on January 14, 2015, from 1:30 PM to 4:30 PM at the Prescott Hotel, 545 Post Street, San Francisco, Room 736. Last week, the US Food and Drug Administration granted the STAR trial conditional approval, a key step for Cytori Cell Therapy to achieve commercial approval as a Class III medical device, as the company must present results from a successful pivotal trial to earn premarket authorization (PMA). The STAR trial is expected to begin enrollment in 2015.
The trial is designed to evaluate the platform’s efficacy as a treatment for scleroderma-related hand function impairment, which is caused by a major reduction in blood flow to the hands and fingers. The upcoming informational session is an exclusive opportunity to gain in-depth information and updates on this rare autoimmune disorder, and learn more about the STAR pivotal trial’s design, along with data from previous related studies.
Frederick G.L. Huetwell Professor of Rheumatology and Associate Professor of Internal Medicine, Dinesh Khanna, MD, MS, is the director of the University of Michigan Scleroderma Program, and was formerly a Clinical Director of University of Californa Los Angeles’ Scleroderma Clinic. He has authored more than 160 peer-reviewed publications and book chapters, and is the recipient of a number of prestigious awards, such as the 2007 Spirit of Leadership Award. The Scleroderma Foundation also selected him as 2011’s “Best Doctor of the Year,” and was elected by his peers as one of 2011-2012’s Best Doctors in America. His research work is funded by the National Institutes of Health.
The STAR trial for Cytori Cell Therapy will utilize the Celution System, which produces an autologous cell product from adipose tissue known as adipose-derived regenerative cells (ADRCs™) to treat approximately 80 patients with hand and finger affectations of scleroderma across 12 clinical sites. Previous studies have shown Cytori Cell Therapy’s groundbreaking ability to improve blood flow, inhibit inflammatory processes, and enhance wound healing.