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Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing
Sponsor: University of Cincinnati
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
AM3101
Injectable drug product.
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