74 Participants Needed

AM3101 for Meniscus Tears

RW
KA
Overseen ByKimberly A Hasselfeld, MS
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: University of Cincinnati

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

BM

Brian M Grawe, MD

Principal Investigator

University of Cincinnati

Are You a Good Fit for This Trial?

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

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
My liver and kidney tests are normal.
See 2 more

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.
See 8 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treated with repair and AM3101Experimental Treatment1 Intervention
Group II: Treated with repair and 0.9% sodium chloride (saline)Placebo Group1 Intervention

Find a Clinic Near You

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+
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