Health TrialsbyHealthPanel

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

ConditionMeniscus Tear
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversity of Cincinnati

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female ≥ 18 and ≤ 40 years old at time of screening.

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

Body mass index (BMI) ≤ 40 kg/m2.

Liver and kidney function panels within normal ranges at time of screening

Disqualifiers

Have any concomitant ligament injury requiring surgical repair or reconstruction other than the ACL.

Have a history of previous meniscus injury that currently needs to be treated or has been treated surgically.

Have evidence of arthritis ≥ Grade III (Outerbridge classification) in the affected compartment or greater than Kellgren Lawrence Grade 3.

Elevated AST or ALT liver enzymes at time of screening

Trial design

Design model

Parallel

Treatments tested in this trial

  • AM3101

    Drug

    Injectable drug product.

  • Saline Placebo

    Drug

    2 mL 0.9% normal saline

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: Treated with repair and AM3101Experimental treatment 1 intervention
Group B: Treated with repair and 0.9% sodium chloride (saline)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Healing Assessed via MRI

Presence or absence of healing assessed via MRI

Time frame
12 months
2

Incidence of Adverse Events

Incidence of adverse events in subjects receiving AM3101 following meniscal repair, as compared to subjects undergoing meniscal repair and injected with a saline solution (placebo).

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Cincinnati

Lead sponsor

United States Department of Defense

Collaborator

Source ClinicalTrials.gov
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