RecruitingPhase 1Phase 2NCT05560477

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


Sponsor

University of Cincinnati

Enrollment

74 participants

Start Date

Apr 26, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called AM3101 and a drug called Saline Placebo for people with meniscus tear. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years to 40 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAM3101

Injectable drug product.

DRUGSaline 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

View Full Details on ClinicalTrials.gov

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NCT05560477


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