Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 40Years
All Genders
ID05560477

A Prospective, Randomized, Controlled, Double-Blinded, Multi-Center 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

21 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

Researchers are evaluating the safety and effectiveness of AM3101 in helping meniscal repair and reducing complications related to failed meniscal repairs. This is a prospective, randomized, controlled, double-blinded clinical trial conducted across multiple centers. The study compares AM3101 with a saline placebo in patients aged 18 to 40 who have meniscus tears, with or without ACL injuries. Participants receive an injection of either AM3101 or a saline solution following meniscal repair surgery. The study groups include one treated with the AM3101 injection and the other with the saline placebo. The primary goal is to assess meniscal healing by MRI at 12 months post-injection and to monitor the safety by tracking adverse events compared to the placebo group. During the study, participants will undergo MRI scans at 12 months to evaluate meniscal tissue integrity. Researchers will also assess adverse events and compare functional outcomes between groups. Participants must comply with study procedures and visit schedules, which include safety monitoring and follow-up visits over the course of one year. The overall participation duration is at least 12 months.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 40Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 to 40 years at time of screening
  • MRI evidence of ACL plus meniscus tear, or isolated meniscus tear
  • Body mass index (BMI) 40 kg/m2 or less
  • Normal liver and kidney function panels at time of screening
  • Willing and able to comply with study procedures and visit schedule
  • Able and willing to sign informed consent approved by IRB
Not Eligible

You will not qualify if you...

  • Any ligament injury requiring surgical repair other than ACL
  • History of previous meniscus injury needing treatment or surgery
  • Evidence of arthritis Grade III or higher in affected compartment
  • Elevated AST or ALT liver enzymes at screening
  • Pregnant, nursing, or planning pregnancy during study participation
  • Known drug or alcohol dependence currently or within last year
  • Participation in another clinical study within last 90 days or during study
  • Any medical condition or circumstances interfering with follow-up visits
  • Any condition preventing proper evaluation of investigational product
  • Known allergic reaction 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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment visit

Participants receive a meniscal repair followed by an injection of either AM3101 or saline placebo to support meniscal healing.

1 treatment visit (in-person)

Follow-up

Duration - 12 months

Participants are monitored for safety and efficacy outcomes including MRI assessment of meniscal healing and incidence of adverse events.

Visits scheduled periodically up to 12 months, including MRI assessments

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

Loading map...

Research Team

K

Kimberly A Hasselfeld, MS

R

Rebekah West

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

Outcomes Following Meniscal Repair With the BEAR Implant: A ...

Meniscus Tear

Actively Recruiting

1 location

Clinical and Instrumental Assessment of Meniscal ROOT Tears ...

Meniscus Tear

Actively Recruiting

1 location

Fibrine Clot-augmented Repair of Longitudinal Meniscus Tears...

Meniscus Tear

Actively Recruiting

2 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Utilization of longitudinal ultrasound to quantify joint soft-tissue changes in a mouse model of posttraumatic osteoarthritis.

Hao Xu, Echoe M Bouta, Ronald W Wood...

https://pubmed.ncbi.nlm.nih.gov/28638676

Longitudinal assessment of synovial, lymph node, and bone volumes in inflammatory arthritis in mice by in vivo magnetic resonance imaging and microfocal computed tomography.

Steven T Proulx, Edmund Kwok, Zhigang You...

https://pubmed.ncbi.nlm.nih.gov/18050199

Local administration of low-dose simvastatin-conjugated gelatin hydrogel for tendon-bone healing in anterior cruciate ligament reconstruction.

Shinya Oka, Tomoyuki Matsumoto, Seiji Kubo...

https://pubmed.ncbi.nlm.nih.gov/23198912

Diagnoses and mechanisms of musculoskeletal injuries in an infantry brigade combat team deployed to Afghanistan evaluated by the brigade physical therapist.

Tanja C Roy

https://pubmed.ncbi.nlm.nih.gov/21882780