NCT05560477 · University of Cincinnati
Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing
What this study is about
The purpose of this clinical trial is to assess the safety and effectiveness 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 forward-looking, randomly assigned, controlled, double-blinded, multi-center study.
View original scientific description
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.
Interventions
DRUG
AM3101
Injectable drug product.
DRUG
Saline Placebo
2 mL 0.9% normal saline
Primary outcome measures
Healing Assessed via MRI
Time frame: 12 months
Presence or absence of healing assessed via MRI
Incidence of Adverse Events
Time frame: 12 months
Incidence of adverse events in subjects receiving AM3101 following meniscal repair, as compared to subjects undergoing meniscal repair and injected with a saline solution (placebo).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female ≥ 18 and ≤ 40 years old at time of screening.
- MRI evidence of ACL plus meniscus tear, or isolated meniscus tear.
- Body mass index (BMI) ≤ 40 kg/m2.
- Liver and kidney function panels within normal ranges at time of screening
- Willing and able to comply with the study procedures and visit schedule, and able to follow oral and written instructions.
- Willing and able to sign an IRB approved informed consent
Exclusion criteria
- Have any concomitant ligament injury requiring surgical repair or reconstruction other than the ACL.
- Have a history of previous meniscus injury that currently needs to be treated or has been treated surgically.
- Have evidence of arthritis ≥ Grade III (Outerbridge classification) in the affected compartment or greater than Kellgren Lawrence Grade 3.
- Elevated AST or ALT liver enzymes at time of screening
- Pregnant or nursing mothers, or women planning on getting pregnant during the time they will be participating in the study.
- Known drug or alcohol dependence currently or within the last year.
- 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.
- 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.
- Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of the investigational product's safety and efficacy.
- Known allergic reaction to simvastatin.
- Patients currently taking simvastatin, or any other drug that is within the statin drug classification family.
Where
- Cincinnati, Ohio
- Cleveland, Ohio
- Portland, Oregon
Collaborators
United States Department of Defense
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 4, 2026 · Source of record for eligibility and locations