Actively Recruiting
Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing
Led by University of Cincinnati · Updated on 2026-05-04
74
Participants Needed
3
Research Sites
213 weeks
Total Duration
On this page
Sponsors
U
University of Cincinnati
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 40 years at screening
- MRI evidence of ACL plus meniscus tear, or isolated meniscus tear
- Body mass index (BMI) of 40 kg/m2 or less
- Normal liver and kidney function at screening
- Willing and able to comply with study procedures and visits
- Able to sign informed consent approved by IRB
You will not qualify if you...
- Any ligament injury requiring surgery other than ACL
- History of previous meniscus injury needing treatment or surgery
- Arthritis Grade III or higher in the affected compartment
- Elevated AST or ALT liver enzymes at screening
- Pregnant, nursing, or planning pregnancy during the study
- Current or recent (past year) drug or alcohol dependence
- Participation in another clinical study within the last 90 days or planned during this study
- Medical conditions or impairments preventing follow-up or rehabilitation
- Conditions preventing proper evaluation of the investigational product
- Known allergy to simvastatin
- Current use of simvastatin or other statin drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Actively Recruiting
2
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
3
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
K
Kimberly A Hasselfeld, MS
CONTACT
R
Rebekah West
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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