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AM3101 for Meniscus Tears

Phase 1 & 2
Recruiting
Led By Brian M Grawe, MD
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing a new injection to help with meniscal repair and reduce complications associated with a failed repair.

Who is the study for?
This trial is for men and women aged 18-40 with MRI evidence of a meniscus tear, either alone or with an ACL tear. Participants must have a BMI ≤ 40 kg/m2, normal liver and kidney function, and be able to follow the study's procedures. Exclusions include severe arthritis, other ligament injuries requiring surgery (except ACL), recent drug/alcohol dependence, current statin use or allergy to simvastatin.Check my eligibility
What is being tested?
The trial tests AM3101 against a saline placebo in aiding meniscal repair after injury. It's designed as a double-blinded study where neither participants nor researchers know who receives the real treatment versus the placebo until after results are collected.See study design
What are the potential side effects?
While specific side effects of AM3101 aren't listed here, common ones from similar treatments may include injection site reactions like pain or swelling, potential allergic reactions to ingredients in the formula, and general discomfort.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Healing Assessed via MRI
Incidence of Adverse Events

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treated with repair and AM3101Experimental Treatment1 Intervention
Syringe containing AM3101 for injection.
Group II: Treated with repair and 0.9% sodium chloride (saline)Placebo Group1 Intervention
Syringe containing commercially available 0.9% sodium chloride for injection.

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor
428 Previous Clinical Trials
634,312 Total Patients Enrolled
United States Department of DefenseFED
861 Previous Clinical Trials
227,120 Total Patients Enrolled
Brian M Grawe, MDPrincipal InvestigatorUniversity of Cincinnati
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

AM3101 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05560477 — Phase 1 & 2
Meniscus Tears Research Study Groups: Treated with repair and AM3101, Treated with repair and 0.9% sodium chloride (saline)
Meniscus Tears Clinical Trial 2023: AM3101 Highlights & Side Effects. Trial Name: NCT05560477 — Phase 1 & 2
AM3101 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05560477 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must I meet in order to participate in this medical experiment?

"This research is seeking 74 individuals aged 18 to 40 who possess lipocalin 1. To be eligible, the prospective patients must meet a range of prerequisites including being male or female, having an MRI confirming ACL and meniscus tear (or isolated meniscus tear) with BMI lower than 40 kg/meter squared, normal liver and kidney functioning, willingness to participate in the trial procedures as well as signing IRB approved informed consent document."

Answered by AI

Could individuals aged 55 and above be included in this clinical experiment?

"This research project is open to participants aged 18-40. Additionally, there are two studies for minors and eight trials specifically catered towards individuals 65 years of age or older."

Answered by AI

Is this research endeavor currently enrolling participants?

"Unfortunately, this medical trial is not actively searching for patients at the moment. It was first advertised on October 1st 2022 and its most recent revision took place on October 12th of the same year. Fortunately, other trials with similar criteria are open to new participants."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
What site did they apply to?
University of Cincinnati
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Knee pain, knee keeps giving way. I'm an active runner and can't afford surgery. I'm going to have arthiritis, I've ran multiple Ultras and Ironman events, I box etc.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing
Brian Grawe 2023. "Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05560477.
~39 spots leftby Apr 2025
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