Human Amniotic Membrane and Mesenchymal Stem Cells Composite (BPI+MSC)

Dr. Soetomo General Hospital

Status: Unknown

Conditions: Brachial Plexus Neuropathies

Treatments: Procedure: Nerve transfer procedure; Procedure: Nerve transfer with HAM-AdMSC composite wrapping

Study type: Interventional

Funder types: Other

Identifiers

NCT04654286

647 / Panke.KKE/ XI / 2016

Details and patient eligibility

About

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

Full 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

Enrollment: 24 estimated patients

Sex: All

Ages: 15 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Control group (Nerve transfer procedure)

Active Comparator group

Description:

Patient will receive nerve transfer procedure without augmentation

Treatment:

Procedure: Nerve transfer procedure

Experimental group (Nerve transfer with HAM-AdMSC composite wrapping)

Experimental group

Description:

Following nerve transfer procedure, the end-to-end anastomosis will be wrapped with HAM-AdMSC composite as augmentation

Treatment:

Procedure: Nerve transfer with HAM-AdMSC composite wrapping