Viewing Study NCT02302157

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Ignite Creation Date: 2025-12-24 @ 6:38 PM
Ignite Modification Date: 2026-02-24 @ 8:51 AM
Study NCT ID: NCT02302157
Status: COMPLETED
Last Update Posted: 2021-07-14
First Post: 2014-11-24
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Dose Escalation Study of AST-OPC1 in Spinal Cord Injury
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013124', 'term': 'Spinal Injuries'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D011782', 'term': 'Quadriplegia'}], 'ancestors': [{'id': 'D019567', 'term': 'Back Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'avi@cellcure.co.il', 'phone': '+972-509105205', 'title': 'Avi Ben Shabat, MD', 'organization': 'Lineage'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Open label study'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'AST-OPC1, Cohort 1', 'description': 'n=3 Dosage of 2 million cells AIS score A', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'AST-OPC1, Cohort 2', 'description': 'n=6 Dosage of 10 million cells AIS score A', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'AST-OPC1, Cohort 3', 'description': 'n=6 Dosage of 20 million cells AIS score A', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'AST-OPC1, Cohort 4', 'description': 'n=6 Dosage of 10 million cells AIS score B', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'AST-OPC1, Cohort 5', 'description': 'n=4 Dosage of 20 million cells AIS score B', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Acute Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Altered Mental Status', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Aspiration Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Bilateral Decubitus Ulcers', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Bilateral Hip Effusions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Bilateral Pyelonephritis due to UTI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Buttock Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cerebrospinal Fluid Leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Escherichia Coli Urinary Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Gastrointestinal Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Infected Epidural Fluid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Left Femoral Shaft Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Non-Traumatic Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Urinary Tract Infection (UTI)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Adverse Events Within 1 Year (365 Days) That Are Related to AST-OPC1 Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AST-OPC1, Cohort 1', 'description': 'n=3 Dosage of 2 million cells AIS score A'}, {'id': 'OG001', 'title': 'AST-OPC1, Cohort 2', 'description': 'n=6 Dosage of 10 million cells AIS score A'}, {'id': 'OG002', 'title': 'AST-OPC1, Cohort 3', 'description': 'n=6 Dosage of 20 million cells AIS score A'}, {'id': 'OG003', 'title': 'AST-OPC1, Cohort 4', 'description': 'n=6 Dosage of 10 million cells AIS score B'}, {'id': 'OG004', 'title': 'AST-OPC1, Cohort 5', 'description': 'n=4 Dosage of 20 million cells AIS score B'}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}, {'value': '69', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One Year', 'description': 'Numbers of adverse events within 1 year (365 days) that are related to AST-OPC1 injection', 'unitOfMeasure': 'Adverse Events', 'reportingStatus': 'POSTED', 'populationDescription': 'All 25 subject experienced at least one (1) AEs. The population description described on comment \\[1\\] above.'}, {'type': 'SECONDARY', 'title': 'Neurological Function as Measured by Upper Extremity Motor Scores and Motor Level on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examinations as Secondary End Point - 365 Days After Injection of AST-OPC1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AST-OPC1, Cohort 1', 'description': 'n=3 Dosage of 2 million AIS A'}, {'id': 'OG001', 'title': 'AST-OPC1, Cohort 2', 'description': 'n=6 Dosage of 10 million AIS A'}, {'id': 'OG002', 'title': 'AST-OPC1, Cohort 3', 'description': 'n=6 Dosage of 20 million AIS A'}, {'id': 'OG003', 'title': 'AST-OPC1, Cohort 4', 'description': 'n=6 Dosage of 10 million AIS B'}, {'id': 'OG004', 'title': 'AST-OPC1, Cohort 5', 'description': 'n=4 Dosage of 20 million AIS B'}], 'classes': [{'title': 'UEMS (Upper Extremities Motor Scale) - Baseline', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '50'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '50'}, {'value': '17', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '50'}, {'value': '22', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '50'}, {'value': '18', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '50'}]}]}, {'title': 'UEMS (Upper Extremities Motor Scale) - Day 365', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '50'}, {'value': '34', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '50'}, {'value': '26', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '50'}, {'value': '28', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '50'}, {'value': '24', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '50'}]}]}, {'title': 'LEMS (Lower Extremities Motor Scale) - Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '50'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '50'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '50'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '50'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '50'}]}]}, {'title': 'LEMS (Lower Extremities Motor Scale) - Day 365', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '50'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '50'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '50'}, {'value': '1', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '50'}, {'value': '1', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '50'}]}]}, {'title': 'LT (Light Touch) - Baseline', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '112'}, {'value': '27', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '112'}, {'value': '22', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '112'}, {'value': '35', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '112'}, {'value': '53', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '112'}]}]}, {'title': 'LT (Light Touch) - Day 365', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '112'}, {'value': '32', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '112'}, {'value': '31', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '112'}, {'value': '46', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '112'}, {'value': '65', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '112'}]}]}, {'title': 'PP (Pin Prick) - Baseline', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '112'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '112'}, {'value': '19', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '112'}, {'value': '25', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '112'}, {'value': '22', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '112'}]}]}, {'title': 'PP (Pin Prick) - Day 365', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '112'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '112'}, {'value': '21', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '112'}, {'value': '28', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '112'}, {'value': '34', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '112'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One Year', 'description': 'The scale is based on the ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury) that measures the severity of Spinal cord injury. The data was collected per time point during the first year (30,60,90,180,270,365). The 365-days time point was pre-specified as Secondary Outcome Measure. High score means better outcome. Units are "Scores on a scale".\n\nThe score is divided to motor scale (0-100) and sensor scale (0-224).\n\nMotor scale is divided to subscale of upper extremity (0-50) and lower extremity (0-50).\n\nUpper and lower extremity are divided to subscale of Right (0-25) + Left (0-25).\n\nEach upper \\& lower extremity is divided to subscale of 5 motor nerve function (0-5).\n\nSensor scale is divided to subscale of light touch (0-112) and pin prick (0-112).\n\nlight touch and pin prick are divided to subscales of Right (0-56) + Left (0-56).\n\nEach right and left light touch and pin prick are divided to subscales of 28 sensor nerve function (0-2)', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AST-OPC1, Cohort 1', 'description': 'n=3 subjects Dosage of 2 million cells AIS score A'}, {'id': 'FG001', 'title': 'AST-OPC1, Cohort 2', 'description': 'n=6 subjects Dosage 10 million cells AIS score A'}, {'id': 'FG002', 'title': 'AST-OPC1, Cohort 3', 'description': 'n=6 subjects Dosage of 20 million cells AIS score A'}, {'id': 'FG003', 'title': 'AST-OPC1, Cohort 4', 'description': 'n=6 subjects Dosage of 10 million AIS score B'}, {'id': 'FG004', 'title': 'AST-OPC1, Cohort 5', 'description': 'n=4 subjects Dosage of 20 million cells AIS score B'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'AST-OPC1, Cohort 1', 'description': 'n=3 Dosage of 2 million cells AIS score A'}, {'id': 'BG001', 'title': 'AST-OPC1, Cohort 2', 'description': 'n=6 Dosage of 10 million cells AIS score A'}, {'id': 'BG002', 'title': 'AST-OPC1, Cohort 3', 'description': 'n=6 Dosage of 20 million cells AIS score A'}, {'id': 'BG003', 'title': 'AST-OPC1, Cohort 4', 'description': 'n=6 Dosage of 10 million cells AIS score B'}, {'id': 'BG004', 'title': 'AST-OPC1, Cohort 5', 'description': 'n=4 Dosage of 20 million cells AIS score B'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.3', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '24.5', 'spread': '7.4', 'groupId': 'BG001'}, {'value': '44.7', 'spread': '14.7', 'groupId': 'BG002'}, {'value': '28.5', 'spread': '14.1', 'groupId': 'BG003'}, {'value': '34.3', 'spread': '20.7', 'groupId': 'BG004'}, {'value': '30.8', 'spread': '14.8', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'The Abbreviated Injury Scale (AIS)', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The baseline characteristics and demographic are described separately by each cohorts per Age, gender, race, height, weight, BMI'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-07', 'size': 1193302, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-12-03T05:17', 'hasProtocol': True}, {'date': '2018-10-03', 'size': 342243, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-12-03T05:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'dispFirstSubmitDate': '2020-07-14', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-12', 'studyFirstSubmitDate': '2014-11-24', 'dispFirstSubmitQcDate': '2020-07-14', 'resultsFirstSubmitDate': '2020-12-15', 'studyFirstSubmitQcDate': '2014-11-25', 'dispFirstPostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-21', 'studyFirstPostDateStruct': {'date': '2014-11-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Adverse Events Within 1 Year (365 Days) That Are Related to AST-OPC1 Injection', 'timeFrame': 'One Year', 'description': 'Numbers of adverse events within 1 year (365 days) that are related to AST-OPC1 injection'}], 'secondaryOutcomes': [{'measure': 'Neurological Function as Measured by Upper Extremity Motor Scores and Motor Level on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examinations as Secondary End Point - 365 Days After Injection of AST-OPC1', 'timeFrame': 'One Year', 'description': 'The scale is based on the ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury) that measures the severity of Spinal cord injury. The data was collected per time point during the first year (30,60,90,180,270,365). The 365-days time point was pre-specified as Secondary Outcome Measure. High score means better outcome. Units are "Scores on a scale".\n\nThe score is divided to motor scale (0-100) and sensor scale (0-224).\n\nMotor scale is divided to subscale of upper extremity (0-50) and lower extremity (0-50).\n\nUpper and lower extremity are divided to subscale of Right (0-25) + Left (0-25).\n\nEach upper \\& lower extremity is divided to subscale of 5 motor nerve function (0-5).\n\nSensor scale is divided to subscale of light touch (0-112) and pin prick (0-112).\n\nlight touch and pin prick are divided to subscales of Right (0-56) + Left (0-56).\n\nEach right and left light touch and pin prick are divided to subscales of 28 sensor nerve function (0-2)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cervical spinal cord injury', 'AST-OPC1', 'SCiStar', 'OPC1', 'Neural cell', 'Trauma spinal cord', 'stemcell transplant', 'Cervical spine injury', 'Paralysis', 'Quadriplegia', 'Tetraplegia', 'Spine injury', 'oligodendrocyte progenitor cell', 'Subacute spinal cord injury'], 'conditions': ['Cervical Spinal Cord Injury', 'Spine Injury', 'Spinal Cord Trauma']}, 'referencesModule': {'references': [{'pmid': '35901693', 'type': 'DERIVED', 'citation': 'Fessler RG, Ehsanian R, Liu CY, Steinberg GK, Jones L, Lebkowski JS, Wirth ED, McKenna SL. A phase 1/2a dose-escalation study of oligodendrocyte progenitor cells in individuals with subacute cervical spinal cord injury. J Neurosurg Spine. 2022 Jul 8;37(6):812-820. doi: 10.3171/2022.5.SPINE22167. Print 2022 Dec 1.'}, {'pmid': '35364569', 'type': 'DERIVED', 'citation': 'McKenna SL, Ehsanian R, Liu CY, Steinberg GK, Jones L, Lebkowski JS, Wirth E, Fessler RG. Ten-year safety of pluripotent stem cell transplantation in acute thoracic spinal cord injury. J Neurosurg Spine. 2022 Apr 1;37(3):321-330. doi: 10.3171/2021.12.SPINE21622. Print 2022 Sep 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety of cross sequential escalating doses of AST-OPC1 administered among 5 cohorts at a single time-point between 21 and 42 days post injury, inclusively, to subjects with subacute cervical spinal cord injuries (SCI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Major Inclusion Criteria:\n\n* Sensorimotor complete, traumatic SCI (ASIA Impairment Scale A) for cohorts 1,2,3\n* Sensorimotor incomplete, traumatic SCI (ASIA Impairment Scale B) for cohorts 4,5\n* Last fully preserved single neurological level (SNL) from C-4 to C-7\n* From 18 through 69 years of age at time of injury\n* Single spinal cord lesion on a post-stabilization magnetic resonance imaging (MRI) scan, with sufficient visualization of the spinal cord injury epicenter and lesion margins to enable post-injection safety monitoring\n* Informed consent for this protocol and the companion long term follow-up protocol must be provided and documented (i.e., signed informed consent forms) no later than 37 days following injury\n* Able to participate in an elective surgical procedure to inject AST-OPC1 21-42 days following SCI\n\nMajor Exclusion Criteria:\n\n* SCI due to penetrating trauma\n* Traumatic anatomical transection or laceration of the spinal cord based on prior surgery or MRI\n* Any concomitant injury that interferes with the performance, interpretation or validity of neurological examinations\n* Inability to communicate effectively with neurological examiner such that the validity of patient data could be compromised\n* Significant organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression\n* History of any malignancy (except non-melanoma skin cancers)\n* Pregnant or nursing women\n* Body mass index (BMI) \\> 35 or weight \\> 300 lbs.\n* Active participation in another experimental procedure/intervention'}, 'identificationModule': {'nctId': 'NCT02302157', 'briefTitle': 'Dose Escalation Study of AST-OPC1 in Spinal Cord Injury', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lineage Cell Therapeutics, Inc.'}, 'officialTitle': 'A Phase 1/2a Dose Escalation Study of AST-OPC1 in Subjects With Subacute Cervical Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'AST-OPC1-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AST-OPC1', 'description': 'Open label, dose escalation, cross-sequential cohort of subjects who receive an injection or two injections of AST-OPC1 at a single time-point', 'interventionNames': ['Biological: AST-OPC1']}], 'interventions': [{'name': 'AST-OPC1', 'type': 'BIOLOGICAL', 'description': 'One injection of 2 million or 10 million AST-OPC1 cells, or 2 injections of 10 million AST-OPC1 cells for a total of 20 million cells; cohort dependent', 'armGroupLabels': ['AST-OPC1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Univ. of California at San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Rancho Los Amigos/USC', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95128', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University/Santa Clara Valley Medical Center', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Shepherd Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University/Magee Rehabilitation', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Edward D Wirth III, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Asterias Biotherapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lineage Cell Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}