Human Amniotic Membrane and Mesenchymal Stem Cells Composite
- Conditions
- Brachial Plexus Neuropathies
- Interventions
- Procedure: Nerve transfer procedureProcedure: Nerve transfer with HAM-AdMSC composite wrapping
- Registration Number
- NCT04654286
- Lead Sponsor
- Dr. Soetomo General Hospital
- Brief Summary
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
- Detailed Description
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group (Nerve transfer procedure) Nerve transfer procedure Patient will receive nerve transfer procedure without augmentation Experimental group (Nerve transfer with HAM-AdMSC composite wrapping) Nerve transfer with HAM-AdMSC composite wrapping Following nerve transfer procedure, the end-to-end anastomosis will be wrapped with HAM-AdMSC composite as augmentation
- Primary Outcome Measures
Name Time Method Active range of motion (AROM) pre-surgery 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 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 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 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.
- Secondary Outcome Measures
Name Time Method Disabilities of the Arm, Shoulder, and Hand (DASH) score at 12 months follow-up 12 months DASH score is a self-assessment of symptoms and function of the entire upper extremity comprising 30 items. Each item consists of five levels of answers (1=no difficulty/symptoms, 2=mild difficulty/symptoms, 3=moderate difficulty/symptoms, 4=severe difficulty/symptoms, and 5=extreme difficulty (unable to do)/symptoms). The scores are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability). Greater DASH scores reflect greater disability (worse outcome).
Pain outcome pre-surgery Pre-surgery Measured by visual analogue scales (VAS). Patients are asked to described their level of pain from the scale 0 to 10 (0 indicating no pain, 1-3 indicating mild pain, 4-6 indicating moderate pain, 7-9 indicating severe pain, and 10 indicating worst, unbearable pain). The lower scores mean a better pain outcome.
Pain outcome at 12 months follow-up 12 months Measured by visual analogue scales (VAS). Patients are asked to described their level of pain from the scale 0 to 10 (0 indicating no pain, 1-3 indicating mild pain, 4-6 indicating moderate pain, 7-9 indicating severe pain, and 10 indicating the worst, unbearable pain). The lower scores mean a better pain outcome.
Short Form-36 (SF-36) score at 12 months follow-up 12 months A generic, multipurpose, short-form health survey comparing the relative burden of diseases consisting of 36 questions which cover eight domains of health namely physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Each domain is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. A higher score indicating a more favourable health state/quality of life (better outcome).
Initial elbow flexion MRC grade 1 (in months) throughout the study duration (12 months), recorded as the first time reported by the patients Measurement of the length of time (in months) for the patients to show initial contraction (achieve MRC grade 1) of elbow flexion. Previous study by Estrella (2011) showed that the average time for brachial plexus injury patients to achieve an elbow flexion grade M3 after nerve transfer procedure was 7.6 months (range, 5-12 months). As the elbow flexion is the most important movement to restore in treating BPI, the investigators aim to compare the length of time (in months) for the patients to achieve initial contraction (MRC grade 1). The sooner the patients achieve initial elbow flexion MRC grade 1, the better the outcome is.
Initial elbow flexion MRC grade 3 (in months) throughout the study duration (12 months), recorded as the first time reported by the patients Measurement of the length of time (in months) for the patients to achieve MRC grade 3 (active movement against gravity) of elbow flexion. Previous study by Estrella (2011) showed that the average time for brachial plexus injury patients to achieve an elbow flexion grade M3 after nerve transfer procedure was 7.6 months (range, 5-12 months). As the elbow flexion is the most important movement to restore in treating BPI, the investigators aim to compare the length of time (in months) for the patients to achieve MRC grade 3. The sooner the patients achieve initial elbow flexion MRC grade 3, the better the outcome is.
Short Form-36 (SF-36) score pre-surgery pre-surgery A generic, multipurpose, short-form health survey comparing the relative burden of diseases consisting of 36 questions which cover eight domains of health namely physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Each domain is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. A higher score indicating a more favourable health state/quality of life (better outcome).
Disabilities of the Arm, Shoulder, and Hand (DASH) score pre-surgery pre-surgery DASH score is a self-assessment of symptoms and function of the entire upper extremity comprising 30 items. Each item consists of five levels of answers (1=no difficulty/symptoms, 2=mild difficulty/symptoms, 3=moderate difficulty/symptoms, 4=severe difficulty/symptoms, and 5=extreme difficulty (unable to do)/symptoms). The scores are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability). Greater DASH scores reflect greater disability (worse outcome).
Trial Locations
- Locations (1)
Cell and Tissue Bank - Regenerative Medicine, Dr. Soetomo General Academic Hospital/ Faculty of Medicine Universitas Airlangga
🇮🇩Surabaya, East Java, Indonesia