NCT02742857

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Bioquark Inc. · Industry
• Sex: All
• Age: 15 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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).

Conditions

• Brain Death

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-07-01
• Primary completion: 2020-08-01
• Completion: 2020-08-01
• First posted: 2016-04-19
• Last updated: 2020-10-01

Locations

1 site across 1 country: India