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RECRUITING
NCT05560477
PHASE1/PHASE2

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

Sponsor: University of Cincinnati

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

74

Start Date

2023-04-26

Completion Date

2027-06

Last Updated

2025-12-17

Healthy Volunteers

No

Conditions

Interventions

DRUG

AM3101

Injectable drug product.

DRUG

Saline Placebo

2 mL 0.9% normal saline

Locations (3)

University of Cincinnati

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States