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

Recruiting Phase 1 Phase 2 Interventional Study
Meniscus Tear
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 40
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
74 (estimated)
Sponsor
University of Cincinnati · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Male or female ≥ 18 and ≤ 40 years old at time of screening. 2. MRI evidence of ACL plus meniscus tear, or isolated meniscus tear. 3. Body mass index (BMI) ≤ 40 kg/m2. 4. Liver and kidney function panels within normal ranges at time of screening 5. Willing and able to comply …
Contacts

Kimberly A Hasselfeld, MS

513-558-1933

hasselky@ucmail.uc.edu

CONTACT

Rebekah West

513-558-1933

westrk@ucmail.uc.edu

CONTACT