Non-randomized, Open-labeled, Interventional, Single Group, Proof of Concept Study With Multi-modality Approach in Cases of Brain Death Due to Traumatic Brain Injury Having Diffuse Axonal Injury

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2020-08-31

Brief Summary

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This is the proof of concept study with multi-modality approach (using intra-thecal bioactive peptides, stem cells, laser and transcranial IV laser and Median Nerve stimulation as adjuvants) in cases of brain death due to traumatic brain injury having diffuse axonal injury to document possibility of reversal of brain death (BD).

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Detailed Description

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Conditions

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Brain Death

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Treatment Group

Group Type EXPERIMENTAL

BQ-A Peptide Extract

Intervention Type BIOLOGICAL

BQ-A Peptide Extract

Mesenchymal Stem Cells

Intervention Type BIOLOGICAL

Mesenchymal Stem Cells

Transcranial Laser Therapy

Intervention Type DEVICE

Transcranial Laser Therapy

Median Nerve Stimulator

Intervention Type DEVICE

Median Nerve Stimulator

Interventions

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BQ-A Peptide Extract

Intervention Type BIOLOGICAL

Mesenchymal Stem Cells

Intervention Type BIOLOGICAL

Transcranial Laser Therapy

Intervention Type DEVICE

Median Nerve Stimulator

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Individuals declared Brain dead from a traumatic brain injury having diffuse axonal injury on MRI
* Not willing for organ donation
* Written informed consent from the legally acceptable representative of the patient