Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing
Trial Parameters
Brief Summary
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.
Eligibility Criteria
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 of previous meniscus injury that currently needs to be treated or has been treated surgically. 3. Have evidence of arthritis ≥ Grade III (Outerbridge classification) in the affected compartment or greater than Kellgren Lawrence Grade 3. 4. Elevated AST or ALT liver enzymes at time of screening 5. Pregnant or nursing mothers, or women planning on getting pregnant during the time they will be particip