AM3101 to improve healing after meniscal repair

A Prospective, Randomized, Controlled, Double-Blinded, Multi-Center, Phase 1/2b Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing

This trial will test whether an injection of AM3101 given after meniscal repair helps meniscus tears heal and reduces complications in adults aged 18 to 40.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 18 Years to 40 Years
• Sex: All
• Sponsor: University of Cincinnati (other)
• Locations: 3 sites (Cincinnati, Ohio and 2 other locations)
• Trial ID: NCT05560477 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled phase 1/2 study enrolls adults with MRI-confirmed isolated or ACL-associated meniscus tears who undergo meniscal repair and receive either AM3101 or a saline injection. The primary efficacy endpoint is meniscal integrity on MRI at 12 months after injection, with safety monitored through adverse event reporting. Secondary endpoints include patient-reported and functional outcomes comparing the AM3101 and placebo groups. The multicenter trial is led by the University of Cincinnati with additional sites in Cleveland and Portland.

Who should consider this trial

Good fit: Adults 18–40 with MRI-confirmed meniscus tears (isolated or with ACL injury), BMI ≤ 40, normal liver and kidney tests, and willingness to attend study visits are ideal candidates.

Not a fit: Patients with prior meniscus surgery on the affected knee, advanced joint arthritis, other ligament injuries requiring repair, abnormal liver enzymes, pregnancy, or inability to attend site visits are unlikely to benefit.

Why it matters

Potential benefit: If successful, AM3101 could increase rates of meniscal healing, lower the need for repeat surgery, and improve knee function.

How similar studies have performed: Prior attempts to use biologic agents or scaffolds to augment meniscal repair have produced mixed results, and AM3101 represents a novel early-phase biologic approach.

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.

Where this trial is running

Cincinnati, Ohio and 2 other locations

• University of Cincinnati — Cincinnati, Ohio, United States (RECRUITING)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (RECRUITING)
• Oregon Health & Science University — Portland, Oregon, United States (RECRUITING)

Study contacts

• Principal investigator: Brian M Grawe, MD — University of Cincinnati
• Study coordinator: Kimberly A Hasselfeld, MS

Conditions: Meniscus Tear, meniscal repair, complications, morbidities