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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

Primary Purpose

Brain Death

Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
BQ-A Peptide Extract
Mesenchymal Stem Cells
Transcranial Laser Therapy
Median Nerve Stimulator
Sponsored by
Bioquark Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Brain Death

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Anupam Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

Outcomes

Primary Outcome Measures

Reversal of brain death as noted in clinical examination or EEG

Secondary Outcome Measures

Cerebrospinal fluid (CSF) analysis of color consistency, cell counts, and microbial evaluation
To signify any signs of aseptic or bacterial meningitis
MRI analysis to analyze any changes in meninges
To signify any signs of aseptic or bacterial meningitis
Pulse
O2 saturation
Blood Pressure
Respiration changes

Full Information

First Posted
April 6, 2016
Last Updated
September 30, 2020
Sponsor
Bioquark Inc.
Collaborators
Revita Life Sciences, Anupam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02742857
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
August 2020 (Actual)
Study Completion Date
August 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bioquark Inc.
Collaborators
Revita Life Sciences, Anupam Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Death

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
BQ-A Peptide Extract
Intervention Description
BQ-A Peptide Extract
Intervention Type
Biological
Intervention Name(s)
Mesenchymal Stem Cells
Intervention Description
Mesenchymal Stem Cells
Intervention Type
Device
Intervention Name(s)
Transcranial Laser Therapy
Intervention Description
Transcranial Laser Therapy
Intervention Type
Device
Intervention Name(s)
Median Nerve Stimulator
Intervention Description
Median Nerve Stimulator
Primary Outcome Measure Information:
Title
Reversal of brain death as noted in clinical examination or EEG
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Cerebrospinal fluid (CSF) analysis of color consistency, cell counts, and microbial evaluation
Description
To signify any signs of aseptic or bacterial meningitis
Time Frame
15 days
Title
MRI analysis to analyze any changes in meninges
Description
To signify any signs of aseptic or bacterial meningitis
Time Frame
15 days
Title
Pulse
Time Frame
15 days
Title
O2 saturation
Time Frame
15 days
Title
Blood Pressure
Time Frame
15 days
Title
Respiration changes
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Himanshu Bansal, MD
Organizational Affiliation
Revita Life Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anupam Hospital
City
Rudrapur
State/Province
Uttaranchal
ZIP/Postal Code
263153
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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