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Tests treatment safety and results for Meniscus Tear
Official title Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing
ClinicalTrials.gov ID: NCT05560477
What this study is testing
What is AM3101?
AM3101 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for meniscus tear.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40
You may be able to join 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.
You likely can't join 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.
See the full eligibility 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
- 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...
- Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of the investigational product's safety and how well it works.
- Known allergic reaction to simvastatin.
- Patients currently taking simvastatin, or any other drug that is within the statin drug classification family.
The study team makes the final eligibility decision.
Where it's taking place
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cincinnati, Ohio, United States; Cleveland, Ohio, United States; Portland, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.