The Efficacy of Using Allogeneic Adipose-derived Mesenchymal Stem Cells and Human Amniotic Membrane (AAdMSC-HAM) Composite for Supraspinatus Tendon Repair Augmentation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Active range of motion (AROM) at 12 months follow-up
研究概览
简要总结
This is a non-randomized clinical trial conducted in a single tertiary hospital which investigates the efficacy of allogeneic adipose-derived mesenchymal stem cells and human amniotic membrane (AAdMSC-HAM) composite for supraspinatus tendon repair augmentation
详细描述
Supraspinatus tendon tear is the most common factor causing shoulder pain, mainly resulting in discomfort and functional deficit in individuals over the age of 35. Supraspinatus tendon repair surgery represents one of the most widely performed types of orthopedic operation. Nevertheless, concerns persist regarding tendon-to-bone healing during the postoperative period. Despite advancements in surgical technique, re-tear of a previously repaired supraspinatus tendon is a fairly common complication, especially in a larger size tear. Such repair technique employing suture anchor devices alone has not yet produced functional results demonstrating both anatomical and biomechanical properties. Therefore, tendon tissue engineering using a combination of scaffolds, cells, and growth factors stimulation offers a potential solution as a biological augmentation in tendon repair.
Human amniotic membrane (HAM) has been widely used as a natural scaffold in tissue engineering due to many of its unique properties such as providing growth factors, cytokines and tissue inhibitors of metalloproteinases, adequate mechanical strength, and biocompatibility. Whereas, mesenchymal stem cells (MSCs) constitute one of the adult stem cells that promote replacement and repair of damaged tissue along with normal tissue turnover. These MSCs are seeded to the HAM scaffolds to biologically augment tendon repair, with MSCs acting as cytokines/growth factors to stimulate tissue repair. This approach serves as the foundation to conduct the present study. The investigators aim to investigate the efficacy of using allogeneic adipose-derived MSCs and human amniotic membrane (AAdMSC-HAM) composite for supraspinatus tendon repair augmentation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Suffering from complete/total tear of supraspinatus tendon for a duration of fewer than 12 months
- •Diagnosis is established based on clinical condition and ultrasonography or MRI examination
排除标准
- •Patients with comorbid diseases: Diabetes Mellitus, Rheumatoid Arthritis, and other inflammatory diseases.
- •Patients presenting with other related injuries, such as fractures or dislocation around the shoulder joint.
结局指标
主要结局
Active range of motion (AROM) at 12 months follow-up
时间窗: 12 months
Shoulder: flexion, extension, abduction, adduction, external rotation, internal rotation. The tests are performed by two blinded assessor, and expressed in degrees.
Active range of motion (AROM) pre-surgery
时间窗: Pre-surgery
Shoulder: flexion, extension, abduction, adduction, external rotation, internal rotation. The tests are performed by two blinded assessor, and expressed in degrees.
次要结局
- Pain pre-surgery(Pre-surgery Outcome)
- Pain at follow-up 12 months(12 months)
- Disabilities of the Arm, Shoulder, and Hand (DASH) score pre-surgery(Pre-surgery)
- Disabilities of the Arm, Shoulder, and Hand (DASH) score at follow-up 12 months(12 months)
- Constant-Murley Score (CS) at follow-up 12 months(12 months)
- Constant-Murley Score (CS) pre-surgery(Pre-surgery)
- Tear recurrence (re-tear)(Throughout the study duration (12 months), recorded as the first time complained by the patients (i.e. after "n" months).)