NCT02742857

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2016

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

October 1, 2020

Status Verified

September 1, 2020

Enrollment Period

4.1 years

First QC Date

April 6, 2016

Last Update Submit

September 30, 2020

Conditions

Brain Death

Outcome Measures

Primary Outcomes (1)

  • Reversal of brain death as noted in clinical examination or EEG

    15 days

Secondary Outcomes (6)

  • Cerebrospinal fluid (CSF) analysis of color consistency, cell counts, and microbial evaluation

    15 days

  • MRI analysis to analyze any changes in meninges

    15 days

  • Pulse

    15 days

  • O2 saturation

    15 days

  • Blood Pressure

    15 days

  • +1 more secondary outcomes

Study Arms (1)

Treatment Group

EXPERIMENTAL
Biological: BQ-A Peptide ExtractBiological: Mesenchymal Stem CellsDevice: Transcranial Laser TherapyDevice: Median Nerve Stimulator

Interventions

BQ-A Peptide ExtractBIOLOGICAL

BQ-A Peptide Extract

Treatment Group
Mesenchymal Stem CellsBIOLOGICAL

Mesenchymal Stem Cells

Treatment Group
Transcranial Laser TherapyDEVICE

Transcranial Laser Therapy

Treatment Group
Median Nerve StimulatorDEVICE

Median Nerve Stimulator

Treatment Group

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Metallic clips/ metal implants or intracranial implants in the brain.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anupam Hospital

Rudrapur, Uttarakhand, 263153, India

Location

MeSH Terms

Conditions

Brain Death

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesComaUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Himanshu Bansal, MD

    Revita Life Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2016

First Posted

April 19, 2016

Study Start

July 1, 2016

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

October 1, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share

Locations

IN(1)