Cytori Therapeutics, Inc. tells us that a 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.
Background
An estimated 850,000 patients undergo surgical procedures to address meniscus injuries each year on top of over 200,000 ACL ruptures, half of which are repaired. This makes these two procedures among the most commonly performed sports-related knee procedures.
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 such it may be a prime candidate for use as an adjunct to procedures that rely on autologous tissue healing, procedures such as ACL reconstruction and meniscal repair.
Cytori has already initiated an ACL study, preliminary results of which indicated no safety related concerns and possible efficacy: All patients recovered without any complications and patients appeared to enjoy accelerated return to daily activities compared with a historical control group 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.
So then to the meniscus study, an investigator-initiated, 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.
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.
The principal investigator and treating surgeon was luminary arthroscopist and ligament reconstruction specialist Dr. Ramon Cugat, Co-Director of the Orthopedic Institute, Hospital Quiron Barcelona.
Investigator comments
“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. Cugat.
Company comments
“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.”
Source: Business Wire
