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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

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ClinicalTrials.gov Identifier: NCT02742857
Recruitment Status : Recruiting
First Posted : April 19, 2016
Last Update Posted : January 18, 2018
Sponsor:
Collaborators:
Revita Life Sciences
Anupam Hospital
Information provided by (Responsible Party):
Bioquark Inc.

April 6, 2016
April 19, 2016
January 18, 2018
July 2018
July 2018   (Final data collection date for primary outcome measure)
Reversal of brain death as noted in clinical examination or EEG [ Time Frame: 15 days ]
Same as current
Complete list of historical versions of study NCT02742857 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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).
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Brain Death
  • 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
Experimental: Treatment Group
Interventions:
  • Biological: BQ-A Peptide Extract
  • Biological: Mesenchymal Stem Cells
  • Device: Transcranial Laser Therapy
  • Device: Median Nerve Stimulator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Same as current
July 2018
July 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
15 Years to 65 Years   (Child, Adult, Older Adult)
Yes
Contact: Ira S Pastor 267-507-6155 pastor@bioquark.com
Contact: Himanshu Basnal, MD 9634501234 hbansal@drhbf.org
India
 
 
NCT02742857
BQ12016
AAH -01-2016 ( Other Identifier: Anupam Hospital )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Bioquark Inc.
Bioquark Inc.
  • Revita Life Sciences
  • Anupam Hospital
Principal Investigator: Himanshu Bansal, MD Revita Life Sciences
Bioquark Inc.
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP