Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing (NCT05560477) | Clinical Trial Compass
RecruitingPhase 1/2
Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing
United States74 participantsStarted 2023-04-26
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.