A Phase II Study to Evaluate Autologous Stromal Vascular Fraction Cell Therapy to Improve the Repair of Chronically Rotator Cuff Tears
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change in scapular plane abduction strength from baseline, and additional isometric, isokinetic strength measurements to assess supraspinatus function.
研究概览
简要总结
Rotator cuff disease is one of the most prevalent musculoskeletal conditions across the world. Patients with chronic rotator cuff tears often have substantial muscle atrophy and fatty infiltration. Surgical repair of the tear does not reverse the atrophy, and many patients continue to experience weakness, pain, and a persistent reduction in the quality of life. An important limitation in our ability to successfully rehabilitate these injuries postoperatively and return patients to normal function has to do with the poor quality of the muscle and tendon after rotator cuff repair. The stromal vascular fraction (SVF) of subcutaneous adipose tissue is highly enriched with cells (SVFCs) that can both directly participate in tissue regeneration by differentiating into myogenic and tenogenic cells, and indirectly by secreting growth factors and small molecules which activate pathways associated with healthy tissue regeneration. High numbers of autologous SVFCs can be isolated using the cost-effective, intraoperative Icellator (Tissue Genesis, Honolulu, HI) point-of-care system. This clinical trial will be determine if the use of SVFCs can enhance outcomes for patients who are undergoing surgical repair of a torn supraspinatus rotator cuff.
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
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females
- •Age 45-65 years old at the time of enrollment
- •Full-thickness supraspinatus tendon tear with endon retraction ≤ 3 cm
- •Magnetic resonance imaging Goutallier score ≤ grade 2
- •Completed at least 6 weeks of standard physical therapy but continue to have pain and limited function (failed physical therapy)
- •Sufficient subcutaneous abdominal adipose tissue to allow the recovery of 60-120cc of lipoaspirate
- •Must pass standard of care blood work screening
排除标准
- •Any tears of any cuff tendon other than the supraspinatus
- •Magnetic resonance imaging Goutallier scores ≥ 3
- •Frank signs of glenohumeral osteoarthritis on magnetic resonance imaging
- •A history of previous rotator cuff repair
- •A history of upper extremity fracture or other moderate to severe upper extremity trauma
- •A BMI < 20 or > 35
- •Pregnant or breast feeding
- •Premenopausal women who are not using contraception
- •Previous abdominal liposuction or any major open abdominal surgery
- •Type I or type II diabetes, or glycated hemoglobin (hemoglobin A1C) values > 6.5 or other metabolic disorders
- •Hypercholesterolemia (total cholesterol ≥240mg/dL)
- •History of cancer
- •Autoimmune disorder or HIV+ status
- •Use of nicotine products
- •Have any other history of major medical illness, disease or other relevant orthopaedic disability
- •Who do not speak English
- •Liodcaine allergy
研究组 & 干预措施
Placebo
Patients will receive an injection of vehicle (Ringer's solution) into their supraspinatus muscle and tendon at the time of rotator cuff repair
干预措施: Ringer's solution (Device)
Cell Therapy
Patients will receive an injection of stromal vascular fraction material suspended in vehicle (Ringer's solution) into their supraspinatus muscle and tendon at the time of rotator cuff repair
干预措施: Autologous Stomal Vascular Fraction Material (Device)
结局指标
主要结局
Change in scapular plane abduction strength from baseline, and additional isometric, isokinetic strength measurements to assess supraspinatus function.
时间窗: 2 weeks prior to surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery
次要结局
- Change in Penn Shoulder score, ASES score and Short Form Global Health scale (PROMIS-SF) from baseline (range 0 minimum to 30 maximum)(2 weeks prior to surgery, 6 weeks after surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery)
- Change in supraspinatus muscle stiffness from baseline, measured by ultrasound shear wave elastrography(1 month prior to surgery, 6 months after surgery, 24 months after surgery)
- Change in fatty infiltration from baseline, measured by magnetic resonance imaging(1 month prior to surgery, 6 months after surgery, 24 months after surgery)