KFAR SABA, Israel, Dec. 9, 2019 /PRNewswire/ -- CartiHeal, developer of Agili-C™, a proprietary implant for the treatment of cartilage lesions in arthritic and non-arthritic joints, announced today that the external and independent Endpoint Adjudication Committee (EAC) performed the first Interim Analysis (IA) on the study data following enrollment of the 250th Subject into the study. The EAC reviewed the IA safety and efficacy results and recommended to stop accrual for anticipated success.
The Agili-C™ clinical study is designed to evaluate the Agili-C™ implant over the current Surgical Standard of Care (SSOC) - microfracture and debridement, for the treatment of joint surface lesions.
The Agili-C™ IDE study is a multicenter, 2:1 randomized, open-label and controlled trial. The primary endpoint is change from baseline to 24 months in the average Overall KOOS score (Pain, Symptoms, QOL, ADL & Sports). The study design uses a Bayesian model and flexible sample size, with a minimum of 250 Subjects, up to a maximum number of 500 enrolled Subjects.
According to the study design, the first Interim Analysis took place following enrollment of the first 250 Subjects.
Based on pre-specified criteria early completion of enrollment was advised since the predictive probability of trial success with the current sample size is >0.95.
Following the IA positive results, enrollment was stopped. Enrolled Subjects will continue follow-up according to the study's investigational plan.
In total 251 Subjects were enrolled, over a period of 2 years, in 26 sites in the US, Europe and Israel. Of these, 167 Subjects were enrolled into the Agili-C™ study arm and 84 Subjects were enrolled into the control arm of the study; consistent with the 2:1 randomization ratio. The study includes both mild to moderate osteoarthritis and focal defects without arthritic changes; approximately half of the enrolled Subjects have osteoarthritis. The study hypothesis is that Agili-C™ will be superior to the current Surgical Standard of Care (debridement or microfracture).
CartiHeal, a privately-held medical device company headquartered in Israel and New Jersey, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.
CartiHeal's cell-free, off-the-shelf implant is CE marked for use in cartilage and osteochondral defects. Agili-C™ has been implanted in over 500 study patients with knee, ankle, and great toe cartilage lesions in a series of clinical trials at leading centers in Europe and Israel – treating a broad spectrum of cartilage lesions, from single focal lesions to multiple and large defects in osteoarthritic patients.
In the United States, the Agili-C™ implant is not available for sale – it is an investigational device limited for use in the IDE clinical study.