University of Cincinnati
The purpose of this clinical trial is to assess the safety and efficacy of AM3101 to facilitate meniscal repair and reduce the incidence of non-healing complications and morbidities associated with a failed meniscal repair. This is a prospective, randomized, controlled, double-blinded, multi-center study.
Primary Efficacy Objective: Assess the efficacy of AM3101 by evaluating the integrity of repaired meniscal tissue assessed via MRI at 12 months following injection with AM3101 as compared to the integrity of meniscal tissue at 12 months in the control group injected with a saline solution (placebo). Primary Safety Objective: Assess the safety of AM3101 by evaluating the incidence of individual adverse events and comparing these adverse event rates to incidence rates for the control group injected with a saline solution (placebo). Secondary Objective: Assess and compare functional outcomes in…
Inclusion Criteria: 1. Male or female ≥ 18 and ≤ 40 years old at time of screening. 2. MRI evidence of ACL plus meniscus tear, or isolated meniscus tear. 3. Body mass index (BMI) ≤ 40 kg/m2. 4. Liver and kidney function panels within normal ranges at time of screening 5. Willing and able to comply with the study procedures and visit schedule, and able to follow oral and written instructions. 6. Willing and able to sign an IRB approved informed consent Exclusion Criteria: 1. Have any concomitant ligament injury requiring surgical repair or reconstruction other than the ACL. 2. Have a history…
Injectable drug product.
2 mL 0.9% normal saline
Arctuva estimate
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