Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
Study NCT ID:
NCT01217008
Status:
COMPLETED
Last Update Posted:
2020-06-18
First Post:
2010-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of GRNOPC1 in Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'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': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-16', 'studyFirstSubmitDate': '2010-10-06', 'studyFirstSubmitQcDate': '2010-10-07', 'lastUpdatePostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'One year', 'description': 'The primary endpoint is safety, as measured by the frequency and severity of adverse events within 1 year (365 days) of GRNOPC1 injection that are related to GRNOPC1, the injection procedure used to administer GRNOPC1, and/or the concomitant immunosuppression administered.'}], 'secondaryOutcomes': [{'measure': 'Neurological function', 'timeFrame': 'One year', 'description': 'The secondary endpoint is neurological function as measured by sensory scores and lower extremity motor scores on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examinations.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Spinal Cord Injury', 'GRNOPC1'], 'conditions': ['Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the safety of GRNOPC1 administered at a single time-point between 7 and 14 days post injury, inclusive, to patients with neurologically complete spinal cord injuries (SCI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Major Inclusion Criteria:\n\n* Neurologically complete, traumatic SCI (ASIA Impairment Scale A), zone of partial preservation \\< 5 levels\n* Last fully preserved neurological level from T-3 through T-11\n* From 18 through 65 years of age at time of injury\n* Single spinal cord lesion\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 11 days following injury\n* Able to participate in an elective surgical procedure to inject GRNOPC1 7-14 days following SCI\n\nMajor Exclusion Criteria:\n\n* SCI due to penetrating trauma\n* Traumatic anatomical transection or laceration of the spinal cord\n* Any concomitant injury or pre-existing condition that interferes with the performance, interpretation or validity of neurological examinations\n* Inability to communicate effectively with neurological examiner\n* Significant organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression\n* History of any malignancy\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': 'NCT01217008', 'briefTitle': 'Safety Study of GRNOPC1 in Spinal Cord Injury', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lineage Cell Therapeutics, Inc.'}, 'officialTitle': 'A Phase 1 Safety Study of GRNOPC1 in Patients With Neurologically Complete, Subacute, Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'CP35A007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GRNOPC1', 'description': 'Subjects who receive an injection of GRNOPC1', 'interventionNames': ['Biological: GRNOPC1']}], 'interventions': [{'name': 'GRNOPC1', 'type': 'BIOLOGICAL', 'description': 'One injection of 2 million GRNOPC1 cells.', 'armGroupLabels': ['GRNOPC1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Palo Alto/San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University/Santa Clara Valley Medical Center'}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Shepherd Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center/Kernan Orthopaedics and Rehabilitation Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'The Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lineage Cell Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}