Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing

Eligibility 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
• 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 participating in the study.
• 6. Known drug or alcohol dependence currently or within the last year.
• 7. Participating concurrently in another clinical study or have participated in a clinical study within the last 90 days, or intend to during the course of the study.
• 8. Any medical condition or other circumstances that might interfere with the ability to return for follow-up visits in the judgment of the Investigator, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the subject unable to perform appropriate postoperative rehabilitation.
• 9. Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of the investigational product's safety and efficacy.
• 10. Known allergic reaction to simvastatin.
• 11. Patients currently taking simvastatin, or any other drug that is within the statin drug classification family.