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New injection aims to boost meniscus healing after surgery

NCT ID NCT05560477

Disease control Sponsor: University of Cincinnati Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests an injectable drug called AM3101 to see if it can improve healing of meniscus tears in the knee after surgical repair. About 74 people aged 18 to 40 with a torn meniscus will be randomly assigned to receive either AM3101 or a saline placebo during surgery. The trial is double-blinded, meaning neither patients nor doctors know who gets the real drug, and will track healing via MRI and any side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AM3101 (an injectable drug)
What this could lead to
If it works, this could lead to a treatment that helps meniscus tears heal better after surgery, reducing the need for repeat procedures.
What could go wrong
This is an early phase 1/2b trial with only 74 people, so results may not apply widely. The drug could also cause side effects or not improve healing compared to placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 74 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Meniscus tear

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45267, United States

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