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Trial record 1 of 1 for:    bioquark
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02742857
Recruitment Status : Completed
First Posted : April 19, 2016
Last Update Posted : October 1, 2020
Sponsor:
Collaborators:
Revita Life Sciences
Anupam Hospital
Information provided by (Responsible Party):
Bioquark Inc.

Study Description
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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
Brain Death Biological: BQ-A Peptide Extract Biological: Mesenchymal Stem Cells Device: Transcranial Laser Therapy Device: Median Nerve Stimulator Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : July 2016
Actual Primary Completion Date : August 2020
Actual Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Reversal of brain death as noted in clinical examination or EEG [ Time Frame: 15 days ]

Secondary Outcome Measures :
  1. 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

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

  3. Pulse [ Time Frame: 15 days ]
  4. O2 saturation [ Time Frame: 15 days ]
  5. Blood Pressure [ Time Frame: 15 days ]
  6. Respiration changes [ Time Frame: 15 days ]

Eligibility Criteria
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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02742857


Locations
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India
Anupam Hospital
Rudrapur, Uttaranchal, India, 263153
Sponsors and Collaborators
Bioquark Inc.
Revita Life Sciences
Anupam Hospital
Investigators
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Principal Investigator: Himanshu Bansal, MD Revita Life Sciences
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Bioquark Inc.
ClinicalTrials.gov Identifier: NCT02742857    
Other Study ID Numbers: BQ12016
AAH -01-2016 ( Other Identifier: Anupam Hospital )
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Death
Diffuse Axonal Injury
Death
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
Brain Injuries, Diffuse