Brain Death
Conditions
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).
Interventions
BIOLOGICALMesenchymal Stem Cells
Mesenchymal Stem Cells
Transcranial Laser Therapy
DEVICEMedian Nerve Stimulator
Median Nerve Stimulator
BIOLOGICALBQ-A Peptide Extract
BQ-A Peptide Extract
Sponsors
Revita Life Sciences
Anupam Hospital
Bioquark Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reversal of brain death as noted in clinical examination or EEG | 15 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MRI analysis to analyze any changes in meninges | 15 days | To signify any signs of aseptic or bacterial meningitis |
| Pulse | 15 days | — |
| Cerebrospinal fluid (CSF) analysis of color consistency, cell counts, and microbial evaluation | 15 days | To signify any signs of aseptic or bacterial meningitis |
| Blood Pressure | 15 days | — |
| Respiration changes | 15 days | — |
| O2 saturation | 15 days | — |
Countries
India
Outcome results
None listed