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

May 1, 2023 updated by: Brian Grawe, University of Cincinnati

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

74

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati
        • Contact:
        • Contact:
        • Principal Investigator:
          • Brian M Grawe, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female ≥ 18 and ≤ 40 years old at time of screening.
  2. MRI evidence of ACL plus meniscus tear, or isolated meniscus tear.
  3. Body mass index (BMI) ≤ 40 kg/m2.
  4. Liver and kidney function panels within normal ranges at time of screening
  5. Willing and able to comply with the study procedures and visit schedule, and able to follow oral and written instructions.
  6. Willing and able to sign an IRB approved informed consent

Exclusion Criteria:

  1. Have any concomitant ligament injury requiring surgical repair or reconstruction other than the ACL.
  2. Have a history of previous meniscus injury that currently needs to be treated or has been treated surgically.
  3. Have evidence of arthritis ≥ Grade III (Outerbridge classification) in the affected compartment or greater than Kellgren Lawrence Grade 3.
  4. Elevated AST or ALT liver enzymes at time of screening
  5. Pregnant or nursing mothers, or women planning on getting pregnant during the time they will be participating in the study.
  6. Known drug or alcohol dependence currently or within the last year.
  7. 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.
  8. 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.
  9. Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of the investigational product's safety and efficacy.
  10. Known allergic reaction to simvastatin.
  11. Patients currently taking simvastatin, or any other drug that is within the statin drug classification family.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing Assessed via MRI
Time Frame: 12 months
Presence or absence of healing assessed via MRI
12 months
Incidence of Adverse Events
Time Frame: 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).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Collaborators

United States Department of Defense

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2023

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

September 23, 2022

First Submitted That Met QC Criteria

September 27, 2022

First Posted (Actual)

September 29, 2022

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 1, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Protocol Number: SM17091
  • UC IRB Number: 2019-0468 (Other Identifier: University of Cincinnati)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A public-use version of the dataset will be constructed with contents to be determined by the study PI. Copies of the public-use version of the dataset will be housed at the University of Cincinnati on a secure server along with suitable documentation of this dataset. The public-use version of the dataset will be exported by CRF in one or more files in simple, widely-accessible formats, e.g., .xls, .csv, and/or SAS datasets. Documentation will be in .pdf files.

IPD Sharing Time Frame

The public-use version of the database will be made 2 years after the study's main paper is published.

IPD Sharing Access Criteria

Outside investigators wishing to conduct analyses using the data will submit a request with objectives, methods, and analysis plan to the PI. Once the request is approved, the public-use version of the dataset, with documentation, will be sent by secure email using e-mail, ftp, or other mutually agreeable transmission method.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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