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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 is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Bioquark Inc.
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: June 15, 2017
Last verified: June 2017
  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: No masking
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

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
Anticipated 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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02742857

Contacts
Contact: Ira S Pastor 267-507-6155 pastor@bioquark.com
Contact: Himanshu Basnal, MD 9634501234 hbansal@drhbf.org

Locations
India
Anupam Hospital Recruiting
Rudrapur, Uttrakhand, Uttaranchal, India, 263153
Contact: Himanshu Bansal, MD    9634501234    hbansal@drhbf.org   
Sponsors and Collaborators
Bioquark Inc.
Revita Life Sciences
Anupam Hospital
Investigators
Principal Investigator: Himanshu Bansal, MD Revita Life Sciences
  More Information

Responsible Party: Bioquark Inc.
ClinicalTrials.gov Identifier: NCT02742857     History of Changes
Other Study ID Numbers: BQ12016
AAH -01-2016 ( Other Identifier: Anupam Hospital )
Study First Received: April 6, 2016
Last Updated: June 15, 2017
Individual Participant Data  
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:
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 June 23, 2017