Impact of BPC-157 on Recovery From Rotator Cuff Repair Surgery
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Shoulder Strength
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled pilot trial investigating the effects of BPC-157 on tendon healing and functional recovery following arthroscopic rotator cuff repair (aRCR). BPC-157 is a synthetic peptide that has demonstrated promising regenerative and anti-inflammatory effects in preclinical animal models of musculoskeletal injury, but it has not yet been studied in formal human clinical trials.
Twenty patients undergoing aRCR will be enrolled and randomly assigned to receive either BPC-157 or a saline placebo. Participants will self-administer subcutaneous injections daily for 90 days following surgery. All other aspects of care will follow the standard postoperative rehabilitation protocol.
The study will assess tendon healing using postoperative MRI, patient-reported outcome measures (PROMs), range of motion (ROM), and muscle strength via handheld dynamometry. Blood samples will also be collected to evaluate biomarkers associated with collagen turnover and inflammation.
The goal of this pilot study is to evaluate the safety, feasibility, and preliminary efficacy of BPC-157 in promoting tendon healing and improving functional outcomes after rotator cuff repair. Results will inform the design of a future larger-scale clinical trial.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females, 18 years old or older
- •Body mass index of 20.0 to 34.9 kg/m2
- •Pre-operative MRI demonstrating a full thickness tear of the posterosuperior rotator cuff less than 2.5 cm in anteroposterior dimension
- •Scheduled for an aRCR at UAMS with Dr. Ryan Hill, Dr. Paul Inclan, or Dr. Justin Rabinowitz
- •COVID-19 negative and/or asymptomatic
排除标准
- •Previous RCR
- •Pregnant or breastfeeding status
- •Current drug and alcohol abuse · History of platelet-rich plasma injection, other platelet-based product or biologic injection in the past 12 months in the ipsilateral shoulder
- •Lack of decisional capacity
- •Having undergone hormone replacement therapy in the last 12 months
- •Having undergone testosterone replacement therapy in the last 12 months
- •Active diagnosis of blood borne infectious disease
- •Documented history or diagnosis of autoimmune disease
研究组 & 干预措施
Sham
Participants in this arm will receive normal saline. Normal saline will be self-administered via subcutaneous injection once daily for 90 days following arthroscopic rotator cuff repair. All participants will follow the standard postoperative rehabilitation protocol in addition to the study intervention.
干预措施: Sham (No Treatment) (Other)
BPC-157 Group
Participants in this arm will receive BPC-157. BPC-157 will be self-administered via subcutaneous injection once daily for 90 days following arthroscopic rotator cuff repair. All participants will follow the standard postoperative rehabilitation protocol in addition to the study intervention.
干预措施: BPC-157 (Drug)
结局指标
主要结局
Shoulder Strength
时间窗: Baseline, 12 weeks, and 5 months post operatively
Isometric shoulder abduction strength will be assessed using a handheld dynamometer. Strength measurements will focus on shoulder abduction and external rotation at 0° abduction. Three trials will be recorded, and the average peak force will be used as the outcome value. Testing will be performed by a blinded evaluator using a standardized protocol.
次要结局
未报告次要终点