A Prospective, Randomized, Controlled, Double-Blinded, Multi-Center, Phase 1/2b Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 6
- 主要终点
- Healing Assessed via MRI
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/m
- •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
排除标准
- •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
- •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 musculoskeletal deficiency that would render the subject unable to perform appropriate postoperative rehabilitation.
- •Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of the investigational product's safety and efficacy.
- •Known allergic reaction to simvastatin.
- •Patients currently taking simvastatin, or any other drug that is within the statin drug classification family.
研究组 & 干预措施
Treated with repair and AM3101
Syringe containing AM3101 for injection.
干预措施: AM3101 (Drug)
Treated with repair and 0.9% sodium chloride (saline)
Syringe containing commercially available 0.9% sodium chloride for injection.
干预措施: Saline Placebo (Drug)
结局指标
主要结局
Healing Assessed via MRI
时间窗: 12 months
Presence or absence of healing assessed via MRI
Incidence of Adverse Events
时间窗: 12 months
Incidence of adverse events in subjects receiving AM3101 following meniscal repair, as compared to subjects undergoing meniscal repair and injected with a saline solution (placebo).
次要结局
未报告次要终点
研究者
Brian Grawe
Principal Investigator
University of Cincinnati