Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04654286
Status:
UNKNOWN
Last Update Posted:
2020-12-07
First Post:
2020-11-18
Brief Title:
Human Amniotic Membrane and Mesenchymal Stem Cells Composite
Sponsor:
Dr Soetomo General Hospital
Organization:
Dr Soetomo General Hospital
Study Overview
Official Title:
Clinical Outcomes of Human Amniotic Membrane and Allogeneic Mesenchymal Stem Cells Composite Augmentation for Nerve Transfer Procedure in Brachial Plexus Injury Patients
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BPIMSC
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 andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None