The independent Endpoint Adjudication Committee (EAC) has completed the first Interim Analysis of the landmark, 250 patient, Agili-C clinical study for treatment of broad spectrum of cartilage defects, including mild to moderate osteoarthritis (OA) of the knee, osteochondral defects and focal cartilage lesions.
The Agili-C IDE [investigational device exemption] study is a multi-center, 2:1 randomized, open-label and controlled study. The primary endpoint is change from baseline to 24 months in the average Overall KOOS score (pain, symptoms, QOL, ADL and Sports).
But, as we detail later in this article, this study stands above other clinical knee studies in the way its patient inclusion and exclusion rules model actual clinical experience with osteoarthritic knees.
The EAC is the first independent body to review the study’s interim results and announced in December 2019 that, based on the data so far, the predictive probability of trial success with the current sample size was greater than 95% and therefore there’s no need to enroll more patients.
The Landmark Agili-C Study
The Agili-C study, sponsored by Israeli-U.S. based CartiHeal Ltd, and funded by Johnson & Johnson, Bioventus, Elron, Accelmed, Access Medical Ventures, aMoon and Peregrine Ventures is one of the most ambitious and promising cartilage repair studies in history.
The following table is a comparison of cartilage repair studies BEFORE Agili-C and then the first-of-its-kind Agili-C study—FDA sanctioned.
| BEFORE Agili-C | Agili-C[1] | |
| Age of Patients | Usually up to 55 | Up to 75 |
| Presence of Osteoarthritis | NO | Yes (mild-moderate) |
| Number of Lesions | 1-2 | Up to 3 |
| Type of Defects | Cartilage | Cartilage and osteochondral |
| Concomitant Procedures | Not allowed | Allowed: meniscectomy and HTO |
| Total Defect Size | 1-4 cm[2] (usually 2 cm2) | 1-7 cm2 |
| Previous Failed Cartilage Treatment | Not allowed[3] | Allowed |
| Control/Comparator: | Microfracture[4] | Microfracture and debridement |
| Malalignment Exclusion? | Yes[5] | No (up to 8⁰) |
| Defect Location: | Single Condyle Only | 1 or 2 Condyles, Condyle & Trochlea, 2 Condyles & Trochlea |
The range of defects is large, just like a typical patient population in any orthopedic clinic.
The age range is huge (21-75 years).
The control arm is, effectively, the current common surgical standard of care, microfracture or debridement—not just microfracture.
The number of defects can be as many as three and malalignment is NOT an exclusion (up to 8°).
