SAN DIEGO--(BUSINESS WIRE)--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.
Internationally, Cytori Cell Therapy has been evaluated in several investigator-initiated pilot studies during the past two years involving professional and amateur athletes with acute and chronic muscle injuries. The goal of these studies is to further the understanding of the potential utility of adipose-derived regenerative cells (ADRCs) in sports and orthopedic conditions.
“We are encouraged by the preliminary data from these pilots and as a result, we have initiated two multi-center registries for related indications in countries where the Celution® System is available for commercial use,” said Christopher J. Calhoun, Cytori’s Chief Executive Officer. “The ACHILLES Registry will collect data from patients with muscle and ligament injuries treated with Cytori Cell Therapy and the RELIEVE Registry will collect data from patients with osteoarthritis. In the United States, the Company has initiated an FDA-approved trial, RECOVER, for hamstring injury.”
The annual incidence of Anterior-cruciate ligament (ACL) reconstruction is more than 250,000 in Europe and the United States. ACL injury is often accompanied with a popping noise and a giving out of the knee, which leads to ongoing pain, swelling, loss of range of motion and joint instability.
Cytori Therapeutics is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and other medical conditions. Our scientific data suggest ADRCs improve blood flow, moderate the inflammatory response and keep tissue at risk of dying alive. As a result, we believe these cells can be applied across multiple “ischemic” conditions. These therapies are made available to the physician and patient at the point-of-care by Cytori’s proprietary technologies and products, including the Celution® System product family. www.cytori.com
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding future events and expectations, including but not limited to full enrollment of the ACL trial being completed this year and the ability of this data to further our understanding of the potential utility of ADRCs in sports and orthopedic conditions. These forward looking statements involve risks and uncertainties, including regulatory uncertainties, the performance of our products in sports and orthopedic indications, dependence on third party performance, as well as other factors which may be beyond the Company’s control. For additional disclosure regarding these and other risks faced by Cytori Therapeutics, we refer the reader to carefully review the section titled "Risk Factors" in Cytori's filings with the SEC, including its annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. Cytori assumes no responsibility to update any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this press release.