Trial | NCT02742857  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    20
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).
Study Started
Jul 31
2016
Primary Completion
Aug 31
2020
Study Completion
Aug 31
2020
Last Update
Oct 01
2020

Biological BQ-A Peptide Extract

BQ-A Peptide Extract

Biological Mesenchymal Stem Cells

Mesenchymal Stem Cells

Device Transcranial Laser Therapy

Transcranial Laser Therapy

Device Median Nerve Stimulator

Median Nerve Stimulator

Treatment Group Experimental

Criteria 

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

Exclusion Criteria:

Metallic clips/ metal implants or intracranial implants in the brain.
Pregnancy
No Results Posted