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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
Primary Efficacy Objective: Assess the efficacy of AM3101 by evaluating the integrity of repaired meniscal tissue assessed via MRI at 12 months following injection with AM3101 as compared to the integrity of meniscal tissue at 12 months in the control group injected with a saline solution (placebo). Primary Safety Objective: Assess the safety of AM3101 by evaluating the incidence of individual adverse events and comparing these adverse event rates to incidence rates for the control group injected with a saline solution (placebo). Secondary Objective: Assess and compare functional outcomes in patients receiving AM3101 following meniscal repair to functional outcomes in the control group injected with a saline solution (placebo).

Official Title
-----------------
A Prospective, Randomized, Controlled, Double-Blinded, Multi-Center, Phase 1/2b Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing

Conditions
-----------------
Meniscus Tear

Intervention / Treatment
-----------------
* Drug: AM3101
* Drug: Saline Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Willing and able to comply with the study procedures and visit schedule, and able to follow oral and written instructions. Willing and able to sign an IRB approved informed consent Exclusion Criteria: 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 Pregnant or nursing mothers, or women planning on getting pregnant during the time they will be participating in the study. Known drug or alcohol dependence currently or within the last year. 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. Any medical condition or other circumstances that might interfere with the ability to return for follow-up visits in the judgment of the Investigator, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the subject unable to perform appropriate postoperative rehabilitation. Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of the investigational product's safety and efficacy. Known allergic reaction to simvastatin. Patients currently taking simvastatin, or any other drug that is within the statin drug classification family.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, controlled, double-blinded, multi-center study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treated with repair and AM3101<br>Syringe containing AM3101 for injection. | Drug: AM3101<br>* Injectable drug product.<br>|
| Placebo Comparator: Treated with repair and 0.9% sodium chloride (saline)<br>Syringe containing commercially available 0.9% sodium chloride for injection. | Drug: Saline Placebo<br>* 2 mL 0.9% normal saline<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing Assessed via MRI | Presence or absence of healing assessed via MRI | 12 months | 
| 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). | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
meniscal repair, complications, morbidities