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 not yet open for participant recruitment. (see Contacts and Locations)

Verified April 2016 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: April 14, 2016

Last verified: April 2016

History of Changes

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:

MedlinePlus related topics: Traumatic Brain Injury

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cerebrospinal fluid (CSF) analysis of color consistency, cell counts, and microbial evaluation [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
To signify any signs of aseptic or bacterial meningitis
MRI analysis to analyze any changes in meninges [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
To signify any signs of aseptic or bacterial meningitis
Pulse [ Time Frame: 15 days ] [ Designated as safety issue: No ]
O2 saturation [ Time Frame: 15 days ] [ Designated as safety issue: No ]
Blood Pressure [ Time Frame: 15 days ] [ Designated as safety issue: No ]
Respiration changes [ Time Frame: 15 days ] [ Designated as safety issue: No ]


Estimated Enrollment:	20
Study Start Date:	April 2016
Estimated Study Completion Date:	April 2017
Estimated Primary Completion Date:	April 2017 (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)
Genders Eligible for Study:	Both
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

Sponsors and Collaborators

Bioquark Inc.

Revita Life Sciences

Anupam Hospital

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:	April 14, 2016
Health Authority:	Institutional Committee for Stem Cell Research & Therapy - Anupam Hospital - India:
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 October 21, 2016

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