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

Sponsor
Bioquark Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02742857
Collaborator
Revita Life Sciences (Other), Anupam Hospital (Other)
20
1
1
49
0.4

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Biological: BQ-A Peptide Extract
  • Biological: Mesenchymal Stem Cells
  • Device: Transcranial Laser Therapy
  • Device: Median Nerve Stimulator
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Actual Study Start Date :
Jul 1, 2016
Actual Primary Completion Date :
Aug 1, 2020
Actual Study Completion Date :
Aug 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Reversal of brain death as noted in clinical examination or EEG [15 days]

Secondary Outcome Measures

  1. Cerebrospinal fluid (CSF) analysis of color consistency, cell counts, and microbial evaluation [15 days]

    To signify any signs of aseptic or bacterial meningitis

  2. MRI analysis to analyze any changes in meninges [15 days]

    To signify any signs of aseptic or bacterial meningitis

  3. Pulse [15 days]

  4. O2 saturation [15 days]

  5. Blood Pressure [15 days]

  6. Respiration changes [15 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anupam Hospital Rudrapur Uttaranchal India 263153

Sponsors and Collaborators

  • Bioquark Inc.
  • Revita Life Sciences
  • Anupam Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bioquark Inc.
ClinicalTrials.gov Identifier:
NCT02742857
Other Study ID Numbers:
  • BQ12016
  • AAH -01-2016
First Posted:
Apr 19, 2016
Last Update Posted:
Oct 1, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 1, 2020