Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-06 @ 5:33 AM
Study NCT ID:
NCT02467634
Status:
TERMINATED
Last Update Posted:
2016-06-02
First Post:
2015-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of HUCNS-SC Subretinal Transplantation in Subjects With GA of AMD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Based on a business decision unrelated to any safety concerns.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-31', 'studyFirstSubmitDate': '2015-06-04', 'studyFirstSubmitQcDate': '2015-06-08', 'lastUpdatePostDateStruct': {'date': '2016-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GA area based on fundus autofluorescence', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Age-Related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD. All subjects will be assigned to HUCNS-SC transplantation.', 'detailedDescription': 'A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with bilateral geographic atrophy (GA) age-related macular degeneration (AMD). All subjects will be assigned to HUCNS-SC transplantation. All subjects will be followed for efficacy and safety for 12 months. An independent data monitoring committee (IDMC) will review adverse events for the duration of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* GA associated with AMD in both eyes. Total area of GA determined by fundus autofluorescence.\n* BCVA of 20/320 or better in each eye at screening assessment\n\nExclusion Criteria:\n\n* Prior or concurrent choroidal neovascularization in either eye by clinical exam and/or fluorescein angiography as determined by the investigator or the reading center.\n* Retinal or macular disease of any other cause in either eye.\n* Diagnosis of glaucoma in either eye.\n* Uncontrolled intraocular pressure in either eye\n* Compromised renal function defined as eGFR \\<60mL/min and urine protein-to-creatinine ration \\>0.3 is spot urine collection.\n* History of or active autoimmune disease.\n* Previous organ, tissue or bone marrow transplantation.\n* Seropositive for HIV, hepatitis B or C, or CMV IgM'}, 'identificationModule': {'nctId': 'NCT02467634', 'acronym': 'RADIANT', 'briefTitle': 'Study of HUCNS-SC Subretinal Transplantation in Subjects With GA of AMD', 'organization': {'class': 'INDUSTRY', 'fullName': 'StemCells, Inc.'}, 'officialTitle': 'A Phase II Proof-of-Concept Study of the Safety and Efficacy of HUCNS-SC Subretinal Transplantation in Subjects With Geographic Atrophy of Age-Related Macular Degeneration', 'orgStudyIdInfo': {'id': 'CL-AMD-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HuCNS-SC', 'description': 'HuCNS-SC sub-retinal transplantation', 'interventionNames': ['Biological: HuCNS-SC sub-retinal transplantation']}], 'interventions': [{'name': 'HuCNS-SC sub-retinal transplantation', 'type': 'BIOLOGICAL', 'description': 'HuCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD', 'armGroupLabels': ['HuCNS-SC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Retina Associates Southwest, PC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Retina Vitreous Associates Medical Group', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '95008', 'city': 'Campbell', 'state': 'California', 'country': 'United States', 'facility': 'Retinal Diagnostic Center', 'geoPoint': {'lat': 37.28717, 'lon': -121.94996}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'Northern California Retina Vitreous Associates', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '94303', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Retina Research Institute of Texas', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Med Ctr.', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Health System', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Eye and Ear Infirmary', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '79606', 'city': 'Abilene', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Research Institute of Texas', 'geoPoint': {'lat': 32.44874, 'lon': -99.73314}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Research Center', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Foundation of the Southwest', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University Of Utah / John A. Moran Eye Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Joel Naor, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'StemCells, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'StemCells, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}