AM3101 for Meniscus Tears

Overseen By Kimberly A Hasselfeld, MS

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Cincinnati

Must not be taking: Statins

Disqualifiers: Arthritis, Pregnancy, Drug dependence, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

74 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests AM3101, a treatment for knee injuries, on patients with meniscal tears needing repair. It aims to help the knee tissue heal better after surgery, reducing complications.

Will I have to stop taking my current medications?

If you are currently taking simvastatin or any other statin drugs, you will need to stop taking them to participate in this trial.

Research Team

Brian M Grawe, MD

Principal Investigator

University of Cincinnati

Eligibility Criteria

This trial is for men and women aged 18-40 with MRI evidence of a meniscus tear, either alone or with an ACL tear. Participants must have a BMI ≤ 40 kg/m2, normal liver and kidney function, and be able to follow the study's procedures. Exclusions include severe arthritis, other ligament injuries requiring surgery (except ACL), recent drug/alcohol dependence, current statin use or allergy to simvastatin.

Inclusion Criteria

I am between 18 and 40 years old.

Willing and able to comply with the study procedures and visit schedule, and able to follow oral and written instructions

MRI evidence of ACL plus meniscus tear, or isolated meniscus tear

Exclusion Criteria

Participating concurrently in another clinical study or have participated in a clinical study within the last 90 days, or intend to during the course of the study

Elevated AST or ALT liver enzymes at time of screening

I do not need surgery for ligament injuries other than the ACL.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either AM3101 or a saline solution following meniscal repair

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including MRI assessments

12 months

Treatment Details

Interventions

• AM3101
• Saline Placebo

Trial Overview The trial tests AM3101 against a saline placebo in aiding meniscal repair after injury. It's designed as a double-blinded study where neither participants nor researchers know who receives the real treatment versus the placebo until after results are collected.

Participant Groups

Group I: Treated with repair and AM3101 Experimental Treatment 1 Intervention

Syringe containing AM3101 for injection.

Group II: Treated with repair and 0.9% sodium chloride (saline) Placebo Group 1 Intervention

Syringe containing commercially available 0.9% sodium chloride for injection.

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+