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

NCT05560477 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

  • Meniscus Tear

Interventions

DRUG

AM3101

Injectable drug product.

DRUG

Saline Placebo

2 mL 0.9% normal saline

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Brian M Grawe, MD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-26
Primary Completion
2027-01-31
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05560477 on ClinicalTrials.gov