Human Amniotic Membrane and Mesenchymal Stem Cells Composite
NCT ID: NCT04654286
Last Updated: 2020-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
24 participants
INTERVENTIONAL
2016-11-17
2022-07-30
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Control group (Nerve transfer procedure)
Patient will receive nerve transfer procedure without augmentation
Nerve transfer procedure
1. Identification of potential donor nerves: phrenic nerve, accessory nerve, intercostal nerve, motor branch nerve innervating long head of triceps muscle, motor branch of ulnar nerve innervating flexor carpi ulnaris (FCU) muscle, and motor branch of median nerve innervating flexor carpi radialis (FCR) muscle.
2. Donor nerve is checked for its viability with an electric stimulator during surgery
3. Viable donor nerve is dissected, transferred to the recipient area, and sutured with end-to-end anastomosis.
Experimental group (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
Nerve transfer with HAM-AdMSC composite wrapping
When the nerve transfer procedure is finished, the end-to-end anastomosis is wrapped by a composite consisted of human amniotic membrane and allogeneic adipose-derived mesenchymal stem cells (HAM-AdMSC)
Interventions
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Nerve transfer procedure
1. Identification of potential donor nerves: phrenic nerve, accessory nerve, intercostal nerve, motor branch nerve innervating long head of triceps muscle, motor branch of ulnar nerve innervating flexor carpi ulnaris (FCU) muscle, and motor branch of median nerve innervating flexor carpi radialis (FCR) muscle.
2. Donor nerve is checked for its viability with an electric stimulator during surgery
3. Viable donor nerve is dissected, transferred to the recipient area, and sutured with end-to-end anastomosis.
Nerve transfer with HAM-AdMSC composite wrapping
When the nerve transfer procedure is finished, the end-to-end anastomosis is wrapped by a composite consisted of human amniotic membrane and allogeneic adipose-derived mesenchymal stem cells (HAM-AdMSC)
Eligibility Criteria
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Inclusion Criteria
* 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
* Traumatic BPI associated with delayed/non-union fracture of the upper extremity affected side.
* Polytrauma conditions which are not fully recovered
15 Years
55 Years
ALL
Yes
Sponsors
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Dr. Soetomo General Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Heri Suroto, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Dr. Soetomo General Academic Hospital/ Universitas Airlangga
Locations
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Cell and Tissue Bank - Regenerative Medicine, Dr. Soetomo General Academic Hospital/ Faculty of Medicine Universitas Airlangga
Surabaya, East Java, Indonesia
Countries
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Central Contacts
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Facility Contacts
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Heri Suroto, MD, PhD
Role: primary
Heri Suroto, MD, PhD
Role: backup
Other Identifiers
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647 / Panke.KKE/ XI / 2016
Identifier Type: -
Identifier Source: org_study_id