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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

NCT02742857 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-10-01

No results posted yet for this study

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).

Conditions

  • Brain Death

Interventions

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

Sponsors & Collaborators

  • Revita Life Sciences

    collaborator UNKNOWN

  • Anupam Hospital

    collaborator OTHER

  • Bioquark Inc.

    lead INDUSTRY

Principal Investigators

  • Himanshu Bansal, MD · Revita Life Sciences

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02742857 on ClinicalTrials.gov