Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2026-01-01 @ 6:03 PM
Study NCT ID:
NCT02742857
Status:
COMPLETED
Last Update Posted:
2020-10-01
First Post:
2016-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001926', 'term': 'Brain Death'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003128', 'term': 'Coma'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-30', 'studyFirstSubmitDate': '2016-04-06', 'studyFirstSubmitQcDate': '2016-04-14', 'lastUpdatePostDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reversal of brain death as noted in clinical examination or EEG', 'timeFrame': '15 days'}], 'secondaryOutcomes': [{'measure': 'Cerebrospinal fluid (CSF) analysis of color consistency, cell counts, and microbial evaluation', 'timeFrame': '15 days', 'description': 'To signify any signs of aseptic or bacterial meningitis'}, {'measure': 'MRI analysis to analyze any changes in meninges', 'timeFrame': '15 days', 'description': 'To signify any signs of aseptic or bacterial meningitis'}, {'measure': 'Pulse', 'timeFrame': '15 days'}, {'measure': 'O2 saturation', 'timeFrame': '15 days'}, {'measure': 'Blood Pressure', 'timeFrame': '15 days'}, {'measure': 'Respiration changes', 'timeFrame': '15 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brain Death']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals declared Brain dead from a traumatic brain injury having diffuse axonal injury on MRI\n* Not willing for organ donation\n* Written informed consent from the legally acceptable representative of the patient\n\nExclusion Criteria:\n\n* Metallic clips/ metal implants or intracranial implants in the brain.\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02742857', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bioquark Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'BQ12016'}, 'secondaryIdInfos': [{'id': 'AAH -01-2016', 'type': 'OTHER', 'domain': 'Anupam Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'interventionNames': ['Biological: BQ-A Peptide Extract', 'Biological: Mesenchymal Stem Cells', 'Device: Transcranial Laser Therapy', 'Device: Median Nerve Stimulator']}], 'interventions': [{'name': 'BQ-A Peptide Extract', 'type': 'BIOLOGICAL', 'description': 'BQ-A Peptide Extract', 'armGroupLabels': ['Treatment Group']}, {'name': 'Mesenchymal Stem Cells', 'type': 'BIOLOGICAL', 'description': 'Mesenchymal Stem Cells', 'armGroupLabels': ['Treatment Group']}, {'name': 'Transcranial Laser Therapy', 'type': 'DEVICE', 'description': 'Transcranial Laser Therapy', 'armGroupLabels': ['Treatment Group']}, {'name': 'Median Nerve Stimulator', 'type': 'DEVICE', 'description': 'Median Nerve Stimulator', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '263153', 'city': 'Rudrapur', 'state': 'Uttarakhand', 'country': 'India', 'facility': 'Anupam Hospital', 'geoPoint': {'lat': 28.98, 'lon': 79.4}}], 'overallOfficials': [{'name': 'Himanshu Bansal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Revita Life Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bioquark Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Revita Life Sciences', 'class': 'UNKNOWN'}, {'name': 'Anupam Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}