SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today that the first patient was enrolled and treated this week in a single arm, open label investigator initiated trial of Cytori Cell Therapy in patients undergoing surgery for traumatic meniscal injuries in the knee.
The principal investigator and treating surgeon was Dr. Ramon Cugat, Co-Director of the Orthopedic Institute, Hospital Quiron Barcelona. This is a parallel study to an ongoing evaluation of Cytori Cell Therapy for anterior cruciate ligament (ACL) repairs. Although follow up is ongoing in the ACL trial, preliminary results presented at the Barcelona Knee Symposium in November 2014, indicated no safety related concerns and possible efficacy.
“Dr. Cugat is a leading expert in treating traumatic knee injuries in elite athletes,” said Dr. Marc H. Hedrick, President and CEO of Cytori Therapeutics. “These trials are important to Cytori because, at minimal cost to us, they provide additional clinical evidence that our therapy can be safely used in treating a multitude of knee conditions.”
The meniscus investigator initiated trial is a two center phase I study of the safety and efficacy of Cytori’s ECCM-50 adipose derived regenerative cell therapy delivered by injection into the surgically repaired meniscus in up to 60 patients. A number of exploratory endpoints will be measured related to functional recovery of the patient after surgical repair. Similar to the ACL repair study, the goal of this trial is to assess whether Cytori Cell Therapy can be safely delivered to the meniscus and whether efficacy can be observed.
“Tears to the meniscus are problematic injuries for active individuals, particularly athletes. Based on the early results from a recent series of 20 patients treated for complete anterior cruciate ligament injuries, we are eager to evaluate whether augmentation surgery with Cytori Cell Therapy will lead to quicker and more complete healing,” said Dr. Ramon Cugat.
The endpoints for the trial include patient reported outcomes questionnaires of pain, function and activity, including the Knee Injury and Osteoarthritis Outcome Score (KOOS), knee pain assessed by visual analogue score, Lysholm Knee Scoring Scale, Tegner Activity Scale, and the Lower Extremity Functional Scale. In addition, the study will evaluate the structure of the meniscus through Magnetic Resonance Imaging (MRI). Patient reported outcome assessments will be performed before and 60, 90, 180 and 365 days after surgery and with MRI before and at 90, 180 and 365 days after surgery.
Preliminary ACL study results demonstrated the procedure was feasible and not associated with safety issues above that seen with a standard small volume liposuction. All patients recovered without any complications. The results were compared to a historical control group of patients who had the same surgical procedure by the same surgical team but without other interventions. Overall, recovery from pain and ability to return to daily activities appeared to be accelerated as a result of the therapeutic enriched bone-patellar tendon-bone transplant. The patient questionnaires and serial MRI scans of the knees following cell therapy were consistent with accelerated healing of the graft. Dr. Cugat and his team are obtaining one year follow up information on the treated patients and intend to report and publish these results in the near future.
ACL and meniscus tears are among the most common sports-related knee injuries and often are sustained simultaneously. According to the American Academy of Orthopedic Surgeons, ACL injuries have an annual incidence of more than 200,000 cases with nearly half undergoing surgical reconstruction. Further, an estimated 850,000 patients undergo surgical procedures to address meniscus injuries each year.
About Cytori Therapeutics, Inc.
Cytori Therapeutics is a late stage cell therapy company developing autologous cell therapies from adipose tissue to treat a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products. For more information visit: www.cytori.com.