A Phase 1 interventional study of BQ-A Peptide Extract and Mesenchymal Stem Cells in Brain Death, sponsored by Bioquark Inc.. Completed at 1 site in India. Open to participants aged 15 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-01.
Sponsored by Bioquark Inc. · Phase 1, Interventional, and Other
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).
74 studies on the registry are indexed under Brain Death; 10 are open to participants now.
This study's enrollment of 20 is below the median of 154 across 39 interventional studies indexed under Brain Death.
Browse Brain Death studies →This is the only study on the registry with Bioquark Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: BQ-A Peptide Extract · Biological: Mesenchymal Stem Cells · Device: Transcranial Laser Therapy · Device: Median Nerve Stimulator
BQ-A Peptide Extract
Mesenchymal Stem Cells
Transcranial Laser Therapy
Median Nerve Stimulator
Reversal of brain death as noted in clinical examination or EEG
Time frame: 15 days
Cerebrospinal fluid (CSF) analysis of color consistency, cell counts, and microbial evaluation
To signify any signs of aseptic or bacterial meningitis
Time frame: 15 days
MRI analysis to analyze any changes in meninges
To signify any signs of aseptic or bacterial meningitis
Time frame: 15 days
Pulse
Time frame: 15 days
O2 saturation
Time frame: 15 days
Blood Pressure
Time frame: 15 days
Respiration changes
Time frame: 15 days
Plan to share: Yes
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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