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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

This study has suspended participant recruitment.
Sponsor:
Collaborators:
Revita Life Sciences
Anupam Hospital
Information provided by (Responsible Party):
Bioquark Inc.
ClinicalTrials.gov Identifier:
NCT02742857
First received: April 6, 2016
Last updated: November 12, 2016
Last verified: November 2016
  Purpose
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 Intervention Phase
Brain Death
Biological: BQ-A Peptide Extract
Biological: Mesenchymal Stem Cells
Device: Transcranial Laser Therapy
Device: Median Nerve Stimulator
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Bioquark Inc.:

Primary Outcome Measures:
  • Reversal of brain death as noted in clinical examination or EEG [ Time Frame: 15 days ]

Secondary Outcome Measures:
  • 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

  • MRI analysis to analyze any changes in meninges [ Time Frame: 15 days ]
    To signify any signs of aseptic or bacterial meningitis

  • Pulse [ Time Frame: 15 days ]
  • O2 saturation [ Time Frame: 15 days ]
  • Blood Pressure [ Time Frame: 15 days ]
  • Respiration changes [ Time Frame: 15 days ]

Estimated Enrollment: 20
Study Start Date: July 2017
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Bioquark Inc.
ClinicalTrials.gov Identifier: NCT02742857     History of Changes
Other Study ID Numbers: BQ12016  AAH -01-2016 
Study First Received: April 6, 2016
Last Updated: November 12, 2016
Individual Participant Data  
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Brain Injuries
Death
Brain Death
Diffuse Axonal Injury
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pathologic Processes
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations

ClinicalTrials.gov processed this record on January 19, 2017