NCT05560477

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Efficacy Objective: Assess the efficacy of AM3101 by evaluating the integrity of repaired meniscal tissue assessed via MRI at 12 months following injection with AM3101 as compared to the integrity of meniscal tissue at 12 months in the control group injected with a saline solution (placebo). Primary Safety Objective: Assess the safety of AM3101 by evaluating the incidence of individual adverse events and comparing these adverse event rates to incidence rates for the control group injected with a saline solution (placebo). Secondary Objective: Assess and compare functional outcomes in patients receiving AM3101 following meniscal repair to functional outcomes in the control group injected with a saline solution (placebo).

Conditions

• Meniscus Tear

Interventions

Type	Name	Description
DRUG	AM3101	Injectable drug product.
DRUG	Saline Placebo	2 mL 0.9% normal saline

Timeline

• Start date: 2023-04-26
• Primary completion: 2026-01-01
• Completion: 2027-06-01
• First posted: 2022-09-29
• Last updated: 2025-12-17

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study