Cytori Therapeutics has announced 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, MD, who presented at the Football Medicine Strategies for Joint & Ligament Injuries, 23rd International Conference on Sports Rehabilitation and Traumatology and commented on the ongoing investigator-initiated, open-label pilot study in Spain in patients undergoing ACL reconstruction using Cytori Cell Therapy.
Cugat states, “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. 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 approved to treat 20 patients who will be followed by both clinical and imaging end points.
The Cytori Therapeutics news release notes that 13 patients have been treated thus far, and full enrollment is expected this year. Data is being evaluated on a rolling basis. The study was initiated in 2013 and was organized by a multidisciplinary team of researchers at Hospital Quiron. Internationally, Cytori Cell Therapy has been evaluated in several investigator-initiated pilot studies during the past 2 years involving 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, as indicated on the Cytori Therapeutics news release.
Christopher J. Calhoun, CEO of Cytori, says, “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.”
Calhouan explains, “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.”
Source: Cytori Therapeutics