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

NCT05560477 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: Protocol Number: SM17091UC IRB Number: 2019-0468
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 3

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.

Conditions

Meniscus Tear

Keywords

meniscal repair; complications; morbidities

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Treated with repair and AM3101

EXPERIMENTAL

Syringe containing AM3101 for injection.

Drug: AM3101

Treated with repair and 0.9% sodium chloride (saline)

PLACEBO COMPARATOR

Syringe containing commercially available 0.9% sodium chloride for injection.

Drug: Saline Placebo

Interventions

AM3101 DRUG

Injectable drug product.

Treated with repair and AM3101

Saline Placebo DRUG

2 mL 0.9% normal saline

Treated with repair and 0.9% sodium chloride (saline)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• United States Department of Defense: collaborator
• University of Cincinnati: lead

Study Sites (3)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

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Related Links

• US Food and Drug Administration. Nonclinical review for triamcinolone acetonide (Zilretta)
• Merck Sharp \& Dohme Corp. Approval package for simvastatin (Zocor). 2011
• US Food and Drug Administration. Retrieved on 02 August 2021from

Study Officials

• Brian M Grawe, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly A Hasselfeld, MS

CONTACT

513-558-1933; hasselky@ucmail.uc.edu

Rebekah West

CONTACT

513-558-1933; westrk@ucmail.uc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, randomized, controlled, double-blinded, multi-center study

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: September 29, 2022
• Study Start: April 26, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: The public-use version of the database will be made 2 years after the study's main paper is published.
• 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.

Locations

US (3)