Human Amniotic Membrane and Mesenchymal Stem Cells Composite

NCT04654286 | Unknown

• 1 other identifier: 647 / Panke.KKE/ XI / 2016
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Brachial Plexus Neuropathies

Keywords

Brachial Plexus Injury; Amniotic Membrane; Mesenchymal Stem Cells; Nerve Transfer

Outcome Measures

Primary Outcomes (4)

• Active range of motion (AROM) pre-surgery

  Shoulder: flexion, extension, abduction, adduction, external rotation, internal rotation. Elbow: flexion and extension. Forearm: pronation and supination. The tests are performed by two blinded assessor, and expressed in degrees.

  Pre-surgery

• Active range of motion (AROM) at 12 months follow-up

  Shoulder: flexion, extension, abduction, adduction, external rotation, internal rotation. Elbow: flexion and extension. Forearm: pronation and supination. The tests are performed by two blinded assessor, and expressed in degrees.

  12 months

• Functional motor power outcome pre-surgery

  Measured by Medical Research Council (MRC) scale. The MRC scale consists of 6 values of motor power evaluation, ranging from 0 to 5 (0=No contraction, 1=Flicker or trace contraction, 2=Active movement but eliminated with gravity, 3=Active movement against gravity, 4=Active movement against gravity and resistance, 5=Normal power). The tests are performed by two blinded assessor. A higher score indicates better functional motor power outcome.

  Pre-surgery

• Functional motor power outcome at 12 months follow-up

  Measured by Medical Research Council (MRC) scale. The MRC scale consists of 6 values of motor power evaluation, ranging from 0 to 5 (0=No contraction, 1=Flicker or trace contraction, 2=Active movement but eliminated with gravity, 3=Active movement against gravity, 4=Active movement against gravity and resistance, 5=Normal power). The tests are performed by two blinded assessor. A higher score indicates better functional motor power outcome.

  12 months

Secondary Outcomes (8)

• Initial elbow flexion MRC grade 1 (in months)

  throughout the study duration (12 months), recorded as the first time reported by the patients

• Initial elbow flexion MRC grade 3 (in months)

  throughout the study duration (12 months), recorded as the first time reported by the patients

• Pain outcome pre-surgery

  Pre-surgery

• Pain outcome at 12 months follow-up

  12 months

• Disabilities of the Arm, Shoulder, and Hand (DASH) score pre-surgery

  pre-surgery

Study Arms (2)

Control group (Nerve transfer procedure)

ACTIVE COMPARATOR

Patient will receive nerve transfer procedure without augmentation

Procedure: Nerve transfer procedure

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

EXPERIMENTAL

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

Procedure: Nerve transfer with HAM-AdMSC composite wrapping

Interventions

Nerve transfer procedure 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.

Control group (Nerve transfer procedure)

Nerve transfer with HAM-AdMSC composite wrapping PROCEDURE

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)

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

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Soetomo General Hospital: lead

Study Sites (1)

Cell and Tissue Bank - Regenerative Medicine, Dr. Soetomo General Academic Hospital/ Faculty of Medicine Universitas Airlangga

Surabaya, East Java, 60286, Indonesia

RECRUITING

MeSH Terms

Conditions

Brachial Plexus Neuropathies

Interventions

Nerve Transfer

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Heri Suroto, MD,PhD

  Dr. Soetomo General Academic Hospital/ Universitas Airlangga

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heri Suroto, MD,PhD

CONTACT

hsuroto2000@yahoo.com

Heri Suroto, MD,PhD

CONTACT

heri-suroto@fk.unair.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: December 4, 2020
• Study Start: November 17, 2016
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2022
• Last Updated: December 7, 2020

Record last verified: 2020-11

Locations

ID (1)