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

Sponsor

University of Cincinnati (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05560477

Collaborator

United States Department of Defense (U.S. Fed)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Meniscus Tear	Drug: AM3101 Drug: Saline Placebo	Phase 1/Phase 2

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective, randomized, controlled, double-blinded, multi-center studyProspective, randomized, controlled, double-blinded, multi-center study

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

A vial of AM3101 is inverted to mix and aspirated into the barrel of a 5cc syringe in a controlled area to ensure sterility. The saline control will be prepared in a similar fashion. The syringes will be labeled with blinding tape and transferred to the surgical suite.

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Treated with repair and AM3101

Syringe containing AM3101 for injection.

Drug: AM3101

Injectable drug product.

Placebo Comparator: Treated with repair and 0.9% sodium chloride (saline)

Syringe containing commercially available 0.9% sodium chloride for injection.

Drug: Saline Placebo

2 mL 0.9% normal saline

Outcome Measures

Primary Outcome Measures

Healing Assessed via MRI [12 months]
Presence or absence of healing assessed via MRI
Incidence of Adverse Events [12 months]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Cincinnati	Cincinnati	Ohio	United States	45267

Sponsors and Collaborators

University of Cincinnati
United States Department of Defense

Investigators

Principal Investigator: Brian M Grawe, MD, University of Cincinnati

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:

Brian Grawe, Principal Investigator, University of Cincinnati

ClinicalTrials.gov Identifier:

NCT05560477

Other Study ID Numbers:

Protocol Number: SM17091
UC IRB Number: 2019-0468

First Posted:

Sep 29, 2022

Last Update Posted:

Oct 17, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Brian Grawe, Principal Investigator, University of Cincinnati

meniscal repair

complications

morbidities

Study Results

No Results Posted as of Oct 17, 2022