Enrollment has been completed in a pilottrial evaluating Cytori Cell Therapy as a potential adjunctive therapy for thetreatment of anterior cruciate ligament (ACL) injury. The study is led by RamonCugat, M.D. PhD with a multidisciplinary team of researchers at Hospital Quironin Barcelona, Spain.
“Having completed enrollment of all of the patients, we believe that CytoriCell Therapy combined with a standard bone-patellar tendon-bone graft may havethe potential to improve ACL reconstruction outcomes,” said Dr. Cugat. “Initialobservations have been impressive and we look forward to presenting data fromthis important study in the near future.”
The study is a 20 patient, open-label pilot trial in Spain to determine thefeasibility of using Cytori Cell Therapy on patients undergoing complete ACLreconstruction. Current ACL repair techniques are generally successful in theshort term but patients are required to progressively return to full activitiesin order to avoid further problems. Patient follow-up will occur at two, four,six and twelve months to assess both clinical and imaging end points, includingsafety of liposuction and injection of cells, qualitative and quantitativeassessments of function, stability and range of motion, and MRI assessment. Thestudy was initiated in 2013 under an approval from the Spanish Agency of Medicinesand Medical Devices (AEMPS) and the Spanish Ministry of Health, Social Servicesand Equality (Ministerio de Sanidad, Servicios Sociales e Igualdad).
Dr. Cugat is President of the Medical Council for the Catalan SoccerDelegation's Health Insurance Company under the Spanish Soccer Federation,President of the Board of Directors of the Garcia Cugat Foundation forBiomedical Research, Professor of the Regenerative Medicine Research Chair ofthe Garcia Cugat Foundation at CEU Cardenal Herrera University, Director of theOrthopaedic Surgical Department in Hospital Quiron, Barcelona, Spain and Headof Trauma and Orthopaedic Surgery in Mutua Patronal Montañesa. Additionalresearchers include Dr. Josep Maria Serra Renom, Dr. Pedro Álvarez, Dr. XavierCuscó, Dr. Roberto Seijas, Dr. Montserrat Garcia Balletbó, Dr. GilbertSteinbacher, Dr. Betina Nishishinya, Dr. Oscar Ares, Dr. Juan José Boffa, Dr.Marta Rius, Dr. Ester Sala, and Dr. Jordi Català.
The annual incidence of Anterior Cruciate Ligament (ACL) reconstruction is morethan 250,000 in Europe and the United States. ACL injury is often accompaniedwith a popping noise and a giving out of the knee, which leads to ongoing pain,swelling, loss of range of motion and joint instability. In the case ofathletes and active individuals, current treatment for ACL injury typicallyinvolves surgery (often involving grafting a piece of hamstring or patellartendon) combined with a rigorous physical therapy and rehabilitation program.Currently, full rehabilitation following ACL reconstruction can take up to sixto nine months. While the success rate for ACL surgeries is generally good,return to pre-injury activity levels varies and repeat injury remains aproblem. Cytori Cell Therapy has the potential to facilitate healing whencombined with current ACL reconstruction techniques through restoration ofblood flow to the graft and modulation of inflammation following surgery.