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

September 30, 2020 updated by: Bioquark Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Uttaranchal
      • Rudrapur, Uttaranchal, India, 263153
        • Anupam Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 63 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reversal of brain death as noted in clinical examination or EEG
Time Frame: 15 days
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebrospinal fluid (CSF) analysis of color consistency, cell counts, and microbial evaluation
Time Frame: 15 days
To signify any signs of aseptic or bacterial meningitis
15 days
MRI analysis to analyze any changes in meninges
Time Frame: 15 days
To signify any signs of aseptic or bacterial meningitis
15 days
Pulse
Time Frame: 15 days
15 days
O2 saturation
Time Frame: 15 days
15 days
Blood Pressure
Time Frame: 15 days
15 days
Respiration changes
Time Frame: 15 days
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bioquark Inc.

Collaborators

Revita Life Sciences
Anupam Hospital

Investigators

  • Principal Investigator: Himanshu Bansal, MD, Revita Life Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

April 6, 2016

First Submitted That Met QC Criteria

April 14, 2016

First Posted (Estimate)

April 19, 2016

Study Record Updates

Last Update Posted (Actual)

October 1, 2020

Last Update Submitted That Met QC Criteria

September 30, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BQ12016
  • AAH -01-2016 (Other Identifier: Anupam Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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