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

Bioquark

Status and phase: Completed; Phase 1

Conditions: Brain Death

Treatments: Device: Transcranial Laser Therapy; Biological: Mesenchymal Stem Cells; Device: Median Nerve Stimulator; Biological: BQ-A Peptide Extract

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02742857

BQ12016

AAH -01-2016 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 20 patients

Sex: All

Ages: 15 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Treatment Group

Experimental group

Treatment:

Device: Transcranial Laser Therapy

Biological: Mesenchymal Stem Cells

Device: Median Nerve Stimulator

Biological: BQ-A Peptide Extract