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 range18 Years – 40 Years
SexALL
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
✕. 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.