RECRUITING

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

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Conditions

Meniscus Tearmeniscal repaircomplicationsmorbidities

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-04-26
Study Completion:2024-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05560477

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.

Ages Eligible for Study:18 Years to 40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female ≥ 18 and ≤ 40 years old at time of screening.
  2. 2. MRI evidence of ACL plus meniscus tear, or isolated meniscus tear.
  3. 3. Body mass index (BMI) ≤ 40 kg/m2.
  4. 4. Liver and kidney function panels within normal ranges at time of screening
  5. 5. Willing and able to comply with the study procedures and visit schedule, and able to follow oral and written instructions.
  6. 6. Willing and able to sign an IRB approved informed consent
  1. 1. Have any concomitant ligament injury requiring surgical repair or reconstruction other than the ACL.
  2. 2. Have a history of previous meniscus injury that currently needs to be treated or has been treated surgically.
  3. 3. Have evidence of arthritis ≥ Grade III (Outerbridge classification) in the affected compartment or greater than Kellgren Lawrence Grade 3.
  4. 4. Elevated AST or ALT liver enzymes at time of screening
  5. 5. Pregnant or nursing mothers, or women planning on getting pregnant during the time they will be participating in the study.
  6. 6. Known drug or alcohol dependence currently or within the last year.
  7. 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. 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. 9. Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of the investigational product's safety and efficacy.
  10. 10. Known allergic reaction to simvastatin.
  11. 11. Patients currently taking simvastatin, or any other drug that is within the statin drug classification family.

Contacts and Locations

Study Contact

Kimberly A Hasselfeld, MS
CONTACT
513-558-1933
hasselky@ucmail.uc.edu
Rebekah West
CONTACT
513-558-1933
westrk@ucmail.uc.edu

Principal Investigator

Brian M Grawe, MD
PRINCIPAL_INVESTIGATOR
University of Cincinnati

Study Locations (Sites)

University of Cincinnati
Cincinnati, Ohio, 45267
United States

Collaborators and Investigators

Sponsor: University of Cincinnati

  • Brian M Grawe, MD, PRINCIPAL_INVESTIGATOR, University of Cincinnati

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 Registration Dates

Study Start Date2023-04-26
Study Completion Date2024-06

Study Record Updates

Study Start Date2023-04-26
Study Completion Date2024-06

Terms related to this study

Keywords Provided by Researchers

  • meniscal repair
  • complications
  • morbidities

Additional Relevant MeSH Terms

  • Meniscus Tear