Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing
ConditionMeniscus Tear
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversity of Cincinnati
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- AM3101
- Saline Placebo
Treatment groups
74 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Cincinnati
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov