University of Cincinnati
Brian Grawe
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.
Meniscus Tear
AM3101
Saline Placebo
Phase 1
Phase 2
Primary Efficacy Objective: Assess the efficacy of AM3101 by evaluating the integrity of repaired meniscal tissue assessed via MRI at 12 months following injection with AM3101 as compared to the integrity of meniscal tissue at 12 months in the control group injected with a saline solution (placebo). Primary Safety Objective: Assess the safety of AM3101 by evaluating the incidence of individual adverse events and comparing these adverse event rates to incidence rates for the control group injected with a saline solution (placebo). Secondary Objective: Assess and compare functional outcomes in patients receiving AM3101 following meniscal repair to functional outcomes in the control group injected with a saline solution (placebo).}}
Study Type : | Interventional |
Estimated Enrollment : | 74 participants |
Masking : | Quadruple |
Masking Description : | A vial of AM3101 is inverted to mix and aspirated into the barrel of a 5cc syringe in a controlled area to ensure sterility. The saline control will be prepared in a similar fashion. The syringes will be labeled with blinding tape and transferred to the surgical suite. |
Primary Purpose : | Treatment |
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 |
Actual Study Start Date : | April 26, 2023 |
Estimated Primary Completion Date : | January 2024 |
Estimated Study Completion Date : | June 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Treated with repair and AM3101 Syringe containing AM3101 for injection. |
Drug: AM3101 |
Placebo Comparator: Treated with repair and 0.9% sodium chloride (saline) Syringe containing commercially available 0.9% sodium chloride for injection. |
Drug: Saline Placebo |
Ages Eligible for Study: | 18 Years to 40 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
University of Cincinnati
Cincinnati, Ohio, United States, 45267