Clinical trial NCT04654286: Human Amniotic Membrane and Mesenchymal Stem Cells Composite
Official title: Clinical Outcomes of Human Amniotic Membrane and Allogeneic Mesenchymal Stem Cells Composite Augmentation for Nerve Transfer Procedure in Brachial Plexus Injury Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brachial Plexus Neuropathies
Keywords: Brachial Plexus Injury
Amniotic Membrane
Mesenchymal Stem Cells
Nerve Transfer
Lead sponsor: Dr. Soetomo General Hospital
Sponsor class: OTHER_GOV
First posted: 2020-12-04
Enrollment: 24
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Active range of motion (AROM) pre-surgery
timeFrame: Pre-surgery
measure: Active range of motion (AROM) at 12 months follow-up
timeFrame: 12 months
measure: Functional motor power outcome pre-surgery
timeFrame: Pre-surgery
measure: Functional motor power outcome at 12 months follow-up
timeFrame: 12 months
Secondary outcomes:
measure: Initial elbow flexion MRC grade 1 (in months)
timeFrame: throughout the study duration (12 months), recorded as the first time reported by the patients
measure: Initial elbow flexion MRC grade 3 (in months)
timeFrame: throughout the study duration (12 months), recorded as the first time reported by the patients
measure: Pain outcome pre-surgery
timeFrame: Pre-surgery
measure: Pain outcome at 12 months follow-up
timeFrame: 12 months
measure: Disabilities of the Arm, Shoulder, and Hand (DASH) score pre-surgery
timeFrame: pre-surgery
measure: Disabilities of the Arm, Shoulder, and Hand (DASH) score at 12 months follow-up
timeFrame: 12 months
measure: Short Form-36 (SF-36) score pre-surgery
timeFrame: pre-surgery
measure: Short Form-36 (SF-36) score at 12 months follow-up
timeFrame: 12 months
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: Cell and Tissue Bank - Regenerative Medicine, Dr. Soetomo General Academic Hospital/ Faculty of Medicine Universitas Airlangga
state: East Java
Study officials:
affiliation: Dr. Soetomo General Academic Hospital/ Universitas Airlangga
name: Heri Suroto, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: