Safety of Autologous Muscle Fiber Fragments for Improved Function of Rotator Cuff Musculature Following Rotator Cuff Repair
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
In this study, a chest muscle sample (biopsy) will be taken and the muscle fibers will be removed from the sample and made into smaller strands or fragments. During this same procedure, those muscle fiber fragments (MFFs) will then be injected directly into the supraspinatus muscle. Once injected, the MFFs will remain in the supraspinatus where Investigators believe the MFF will become part of the participants' existing muscle and provide increased muscle size and strength, improving function (rotator cuff strength and stability).
详细描述
Muscle fiber fragment (MFF) therapy has shown pre-clinical and clinical promise in the treatment of bladder neck insufficiency/incompetent outlet. Fragmentation of muscle fibers derived from autologous muscle tissue can be injected through a needle into the sphincter region. The injected muscle fibers are able to assemble into long muscle fibers in the direction of host muscle fibers. More importantly, muscle progenitor cells residing on the fragmented muscle fibers survive and integrate into host vasculature and nerve to restore damaged muscle function. Preclinical results indicate that this technology can be used to repair and restore damaged sphincter function in urinary incontinence. The development of an autologous, readily available muscle fiber fragment treatment that may involve less risk and recovery time than those associated with the standard surgical therapies and urethral bulking agents, could alter the treatment paradigm of urinary incontinence. The study team hypothesizes that injected MFFs will incorporate into skeletal muscle and re-assemble along the fiber direction. The Investigators anticipate that the MFFs can safely be injected into the atrophied rotator cuff muscle and will help restore the functional contractile properties of the supraspinatus muscle following rotator cuff repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, ages 40 to 80 years
- •Unilateral Disease
- •< 1.5cm tear
排除标准
- •Peripheral Neuropathy
- •Previous Shoulder Surgery
- •Pain Syndrome; cuff arthroplasty
- •Major co-morbidities including, but not limited to, uncontrolled diabetes, cardiovascular, pulmonary, GI, coagulopathies
- •Arthritis of Shoulder
- •Unwilling or unable to comply with post-operative instructions or follow-up visits
- •Auto Immune Disease
- •Complete Subscapularis Tear
- •Teres Minor involvement
- •History of testing positive for HIV, Hep B, Hep C, HTLV-1, HTLV-2
- •Pregnancy
- •Implanted devices containing ferromagnetic material
- •Any implanted electrical stimulation devices (i.e. cochlear implant, defibrillator)
- •Any other condition which the PI feels would be not in the best interest for the patient or the study
结局指标
主要结局
Incidence of Adverse Events
时间窗: 12 months post surgery
The incidence of adverse events will be documented in the areas of product related, biopsy procedure-related, and injection-related reporting for each group.
次要结局
- Fat Free Muscle Volume(Month 1, Month 6, and Month 12)
- Goutallier Score via MRI 1.5+ image analysis(12 weeks, 6 months, and 12 months post operatively)
- Constant Score(12 weeks, 6 months, and 12 months post operatively)
- ASES Shoulder Score(12 weeks, 6 months, and 12 months post operatively)
- Dynamometer measurements(12 weeks, 6 months, and 12 months post operatively)