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

Launched by UNIVERSITY OF CINCINNATI · Sep 27, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called AM3101, which aims to help heal tears in the meniscus, a cartilage in the knee that can be damaged during activities or injuries. The goal is to see if AM3101 can improve the healing process and reduce problems that can occur if the meniscus doesn't heal properly. The study is currently recruiting participants aged 18 to 40 who have specific types of meniscus tears and meet certain health criteria, such as having a healthy weight and normal liver and kidney function.

Participants in the trial will receive either the AM3101 treatment or a placebo (a treatment that has no active ingredients) without knowing which one they are getting, as the study is designed to be blind. This means that neither the participants nor the researchers know who is receiving the actual treatment, which helps ensure fair results. If you decide to participate, you will need to follow the study's schedule and instructions closely. It's important to note that certain conditions, like having other serious knee injuries or specific health issues, may prevent someone from joining the trial. Overall, this study hopes to find out if AM3101 can be a safe and effective option for helping the meniscus heal better after an injury.

Gender

ALL

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 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.