Clinical Outcomes of Human Amniotic Membrane and Allogeneic Mesenchymal Stem Cells Composite Augmentation for Nerve Transfer Procedure in Brachial Plexus Injury Patients
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) pre-surgery
研究概览
简要总结
The purpose of this clinical trial is to investigate the utility of composite wrapping comprising human amniotic membrane and allogeneic adipose-derived mesenchymal stem cells (HAM-AdMSC) for augmentation of nerve transfer procedure in upper TBPI patients
详细描述
Nerve transfer procedure is recognized as the current gold standard for treating traumatic brachial plexus injury (TBPI). However, despite the current major progress in diagnosis and microsurgical repair, the prognosis in TBPI remains unfavorable due to limited donor nerve and compromised regenerative capability of the nervous system arising from prolonged denervation. Therefore, there is a major need to devise new treatment strategies; and one possible approach is to develop cellular therapies to bioengineer new nerve tissue and/or modulate the endogenous regenerative mechanisms within the injured nerve.
Our previous studies have shown that the peripheral nerve tissue engineering approach using human amniotic membrane seeded with allogeneic adipose-derived MSCs to augment axonal regeneration in nerve transfer of TBPI patient revealed promising functional recovery of the shoulder range of motion (ROM). The investigators plan a non-randomized clinical trial in a single center to investigate the use of a hybrid (composite) between human amniotic membrane (HAM) and allogeneic adipose-derived mesenchymal stem cells (AdMSC) as wrapping in the nerve transfer procedure of upper TBPI patients, with a focus on the augmentation of axonal regeneration
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
- 15 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Suffering from upper BPI (C5-C6 and/or C5-C7) for a duration of fewer than 12 months
- •Have no systemic disease (Diabetes Mellitus, Lupus erythematosus, rheumatoid arthritis)
- •Without prior medicamentous treatment history such as corticosteroids
- •Agree to contribute in the study
排除标准
- •Complete BPI (C5-Th1), lower BPI (C8-Th1)
- •Traumatic BPI associated with delayed/non-union fracture of the upper extremity affected side.
- •Polytrauma conditions which are not fully recovered
结局指标
主要结局
Active range of motion (AROM) pre-surgery
时间窗: Pre-surgery
Shoulder: flexion, extension, abduction, adduction, external rotation, internal rotation. Elbow: flexion and extension. Forearm: pronation and supination. The tests are performed by two blinded assessor, and expressed in degrees.
Functional motor power outcome at 12 months follow-up
时间窗: 12 months
Measured by Medical Research Council (MRC) scale. The MRC scale consists of 6 values of motor power evaluation, ranging from 0 to 5 (0=No contraction, 1=Flicker or trace contraction, 2=Active movement but eliminated with gravity, 3=Active movement against gravity, 4=Active movement against gravity and resistance, 5=Normal power). The tests are performed by two blinded assessor. A higher score indicates better functional motor power outcome.
Active range of motion (AROM) at 12 months follow-up
时间窗: 12 months
Shoulder: flexion, extension, abduction, adduction, external rotation, internal rotation. Elbow: flexion and extension. Forearm: pronation and supination. The tests are performed by two blinded assessor, and expressed in degrees.
Functional motor power outcome pre-surgery
时间窗: Pre-surgery
Measured by Medical Research Council (MRC) scale. The MRC scale consists of 6 values of motor power evaluation, ranging from 0 to 5 (0=No contraction, 1=Flicker or trace contraction, 2=Active movement but eliminated with gravity, 3=Active movement against gravity, 4=Active movement against gravity and resistance, 5=Normal power). The tests are performed by two blinded assessor. A higher score indicates better functional motor power outcome.
次要结局
- Disabilities of the Arm, Shoulder, and Hand (DASH) score at 12 months follow-up(12 months)
- Pain outcome pre-surgery(Pre-surgery)
- Pain outcome at 12 months follow-up(12 months)
- Short Form-36 (SF-36) score at 12 months follow-up(12 months)
- Initial elbow flexion MRC grade 1 (in months)(throughout the study duration (12 months), recorded as the first time reported by the patients)
- Initial elbow flexion MRC grade 3 (in months)(throughout the study duration (12 months), recorded as the first time reported by the patients)
- Short Form-36 (SF-36) score pre-surgery(pre-surgery)
- Disabilities of the Arm, Shoulder, and Hand (DASH) score pre-surgery(pre-surgery)