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

Brain Death Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02742857
• Other study ID #: BQ12016
• Secondary ID: AAH -01-2016
• Status: Completed
• Phase: Phase 1
• Start date: July 2016
• Est. completion date: August 2020

Study information

• Verified date: September 2020
• Source: Bioquark Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Death
• Brain Injuries
• Brain Injuries, Traumatic
• Death
• Diffuse Axonal Injury

Intervention

Biological:
• BQ-A Peptide Extract
BQ-A Peptide Extract
• Mesenchymal Stem Cells
Mesenchymal Stem Cells

Device:
• Transcranial Laser Therapy
Transcranial Laser Therapy
• Median Nerve Stimulator
Median Nerve Stimulator

Locations

Country	Name	City	State
India	Anupam Hospital	Rudrapur	Uttaranchal

Sponsors (3)

Lead Sponsor	Collaborator
Bioquark Inc.	Anupam Hospital, Revita Life Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reversal of brain death as noted in clinical examination or EEG		15 days
Secondary	Cerebrospinal fluid (CSF) analysis of color consistency, cell counts, and microbial evaluation	To signify any signs of aseptic or bacterial meningitis	15 days
Secondary	MRI analysis to analyze any changes in meninges	To signify any signs of aseptic or bacterial meningitis	15 days
Secondary	Pulse		15 days
Secondary	O2 saturation		15 days
Secondary	Blood Pressure		15 days
Secondary	Respiration changes		15 days