Brain DeathPhase 1NCT02742857
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
A Phase 1 study testing BQ-A Peptide Extract, Mesenchymal Stem Cells and Transcranial Laser Therapy in people with Brain Death, run by Bioquark Inc. at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Death
- What is being tested?
- BQ-A Peptide Extract, Mesenchymal Stem Cells and Transcranial Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2016to Aug 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Metallic clips/ metal implants or intracranial implants in the brain.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-randomized, Open-labeled, Interventional, Single Group, Proof of Concept Study With Multimodality Approach in Cases of Brain Death Due to Traumatic Brain Injury Having Diffuse Axonal Injury
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
- Being tested
- BQ-A Peptide Extract, Mesenchymal Stem Cells, Transcranial Laser Therapy, Median Nerve Stimulator
- Medical subject headings
- Brain Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BQ-A Peptide ExtractBiological
BQ-A Peptide Extract
Mesenchymal Stem CellsBiological
Mesenchymal Stem Cells
Transcranial Laser TherapyDevice
Transcranial Laser Therapy
Median Nerve StimulatorDevice
Median Nerve Stimulator
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Not described Receives: Biological: BQ-A Peptide Extract; Biological: Mesenchymal Stem Cells; Device: Transcranial Laser Therapy; Device: Median Nerve Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reversal of brain death as noted in clinical examination or EEG
Measured: 15 days
Secondary outcomes (6)
Cerebrospinal fluid (CSF) analysis of color consistency, cell counts, and microbial evaluation
To signify any signs of aseptic or bacterial meningitis
Measured: 15 days
MRI analysis to analyze any changes in meninges
To signify any signs of aseptic or bacterial meningitis
Measured: 15 days
Pulse
Measured: 15 days
O2 saturation
Measured: 15 days
Blood Pressure
Measured: 15 days
Respiration changes
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioquark Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Revita Life Sciences, Anupam Hospital
- Responsible party
- Sponsor
- Investigators
- Himanshu Bansal, MD, Principal investigator, Revita Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742857
- Sponsor's protocol ID
- BQ12016
- Other IDs
- AAH -01-2016
- Status last verified
- Sep 2020
- First submitted
- 6 Apr 2016
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-randomized, Open-labeled, Interventional, Single Group, Proof of Concept Study With Multimodality Approach in Cases of Brain Death Due to Traumatic Brain Injury Having Diffuse Axonal Injury
- ClinicalTrials.gov ID
- NCT02742857
- Acronym / sponsor ID
- BQ12016
- Conditions
- Brain Death
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bioquark Inc.Industry (pharma, biotech, devices)
- Collaborators
- Revita Life Sciences, Anupam Hospital
- Study start
- Jul 2016 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Biological: BQ-A Peptide Extract, Biological: Mesenchymal Stem Cells, Device: Transcranial Laser Therapy, Device: Median Nerve Stimulator |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Metallic clips/ metal implants or intracranial implants in the brain.
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BQ-A Peptide ExtractBQ-A Peptide Extract | Biological | Treatment Group |
| Mesenchymal Stem CellsMesenchymal Stem Cells | Biological | Treatment Group |
| Transcranial Laser TherapyTranscranial Laser Therapy | Device | Treatment Group |
| Median Nerve StimulatorMedian Nerve Stimulator | Device | Treatment Group |
Primary outcome
Reversal of brain death as noted in clinical examination or EEG
Time frame: 15 days
6 secondary outcomes
Cerebrospinal fluid (CSF) analysis of color consistency, cell counts, and microbial evaluation
Time frame: 15 days
MRI analysis to analyze any changes in meninges
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Himanshu Bansal, MD principal investigator
Revita Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BQ-A Peptide Extract, Mesenchymal Stem Cells and Transcranial Laser Therapy in people with Brain Death, run by Bioquark Inc. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reversal of brain death as noted in clinical examination or EEG (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.