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
Study Details
Study Description
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 |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
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
Primary Outcome Measures
- Reversal of brain death as noted in clinical examination or EEG [15 days]
Secondary Outcome Measures
- Cerebrospinal fluid (CSF) analysis of color consistency, cell counts, and microbial evaluation [15 days]
To signify any signs of aseptic or bacterial meningitis
- MRI analysis to analyze any changes in meninges [15 days]
To signify any signs of aseptic or bacterial meningitis
- Pulse [15 days]
- O2 saturation [15 days]
- Blood Pressure [15 days]
- Respiration changes [15 days]
Eligibility Criteria
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
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Anupam Hospital | Rudrapur | Uttaranchal | India | 263153 |
Sponsors and Collaborators
- Bioquark Inc.
- Revita Life Sciences
- Anupam Hospital
Investigators
- Principal Investigator: Himanshu Bansal, MD, Revita Life Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BQ12016
- AAH -01-2016