Phase 12b Study Evaluating Safety and Effectiveness of AM3101 Injection to Support Healing After Meniscal Tear Repair

What this Trial Is About

Researchers are evaluating the safety and effectiveness of AM3101 in helping meniscal repair and reducing complications related to failed meniscal repairs. This is a prospective, randomized, controlled, double-blinded clinical trial conducted across multiple centers. The study compares AM3101 with a saline placebo in patients aged 18 to 40 who have meniscus tears, with or without ACL injuries. Participants receive an injection of either AM3101 or a saline solution following meniscal repair surgery. The study groups include one treated with the AM3101 injection and the other with the saline placebo. The primary goal is to assess meniscal healing by MRI at 12 months post-injection and to monitor the safety by tracking adverse events compared to the placebo group. During the study, participants will undergo MRI scans at 12 months to evaluate meniscal tissue integrity. Researchers will also assess adverse events and compare functional outcomes between groups. Participants must comply with study procedures and visit schedules, which include safety monitoring and follow-up visits over the course of one year. The overall participation duration is at least 12 months.

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