Cytori Therapeutics (NASDAQ: CYTX) today announces the first investigator-initiated study evaluating Cytori Cell Therapy as a potential concomitant treatment for Anterior-cruciate ligament (ACL) injury. The study is led by Ramon Cugat, M.D. PhD. Dr. Cugat is President of the Medical Council for the Catalan Soccer Delegation's Health Insurance Company under the Spanish Soccer Federation, President of the Board of Directors of the Council of the Garcia Cugat Foundation for Regenerative Medicine Research, Professor of the Chair of the Garcia Cugat Foundation at CEU Cardenal Herrera University, Director of the Orthopaedic Surgical Department in Hospital Quiron, Barcelona, Spain and Head of Trauma and Orthopaedic Surgery in Mutua Patronal Montañesa.
Dr. Cugat presented at the Football Medicine Strategies for Joint & Ligament Injuries, 23rd International Conference on Sports Rehabilitation and Traumatology on March 22 and commented on an ongoing investigator-initiated, open-label pilot study in Spain in patients undergoing ACL reconstruction for sports-related injuries using Cytori Cell Therapy. “We are encouraged by the clinical data we have observed in our first series of patients treated with Cytori Cell Therapy in conjunction with our ACL reconstruction procedure,” said Dr. Cugat. “We will continue to evaluate more patients and look forward to presenting our final results of this important study in the near future.”
The study is an investigator-initiated study to determine the feasibility of using Cytori Cell Therapy on patients undergoing complete ACL reconstruction. The study is approved to treat 20 patients who will be followed by both clinical and imaging end points. Thirteen patients have been treated thus far, full enrollment is expected this year and data is being evaluated on a rolling basis. The study was initiated in 2013 under an approval from the Spain Ministry of Health, Social Services and Equality (Ministerio de Sanidad, Servicios Sociales e Igualdad). It was organized by a multidisciplinary team of researchers at Hospital Quiron. The researchers include Dr. Ramon Cugat, Dr. Josep Maria Serra Renom, Dr. Pedro Álvarez, Dr. Javier Cuscó, Dr. Roberto Seijas, Dr. Montserrat Garcia Balletbó, Dr. Gilbert Steinbacher, Dr. Betina Nishishinya, Dr. Oscar Ares, Dr. Juan José Bofa, Dr. Marta Rius, Dr. Ester Sala, and Dr. Jordi Català.