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Human Amniotic Membrane and Mesenchymal Stem Cells Composite

NCT04654286 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-12-07

No results posted yet for this study

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

Conditions

  • Brachial Plexus Neuropathies

Interventions

PROCEDURE

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.

PROCEDURE

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)

Sponsors & Collaborators

  • Dr. Soetomo General Hospital

    lead OTHER_GOV

Principal Investigators

  • Heri Suroto, MD,PhD · Dr. Soetomo General Academic Hospital/ Universitas Airlangga

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-17
Primary Completion
2021-07-30
Completion
2022-07-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04654286 on ClinicalTrials.gov