Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2025-12-27 @ 9:16 PM
Study NCT ID:
NCT01068561
Status:
COMPLETED
Last Update Posted:
2011-09-20
First Post:
2010-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Bone Marrow-Derived Stem Cells Transplantation For Retinitis Pigmentosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-01-09', 'releaseDate': '2013-11-18'}, {'resetDate': '2014-03-03', 'releaseDate': '2014-01-12'}, {'resetDate': '2018-02-01', 'releaseDate': '2017-07-18'}, {'resetDate': '2019-02-19', 'releaseDate': '2018-10-15'}], 'estimatedResultsFirstSubmitDate': '2013-11-18'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012174', 'term': 'Retinitis Pigmentosa'}], 'ancestors': [{'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D058499', 'term': 'Retinal Dystrophies'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, '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': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-19', 'studyFirstSubmitDate': '2010-02-10', 'studyFirstSubmitQcDate': '2010-02-12', 'lastUpdatePostDateStruct': {'date': '2011-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'severe visual loss, defined as a drop in 15 letters on ETDRS visual acuity scale', 'timeFrame': '3-6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Retinitis pigmentosa', 'stem cell', 'bone marrow'], 'conditions': ['Retinitis Pigmentosa']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the short-term safety of a single intravitreal injection of autologous bone marrow stem cells in patients with retinitis pigmentosa.', 'detailedDescription': 'A prospective phase I, nonrandomized open-label study of retinitis pigmentosa patients with best-corrected ETDRS visual acuity (BCVA) worse than 20/200. Standardized ophthalmic evaluation will be perform at baseline and at weeks 1, 4,12 and 24 (±1) following intravitreal injection of 10 x 106 bone marrow stem cells/ 0,1ml . Three measures will be used to evaluate the short-term safety of intravitreal of ABMDSC: 1) severe visual loss, defined as a drop in 15 letters on ETDRS visual acuity scale; 2) decrease in ERG response; 3) decrease in 5 square degrees on visual field; secondary safety outcomes : 1) increase in intra-ocular inflammation defined herein as anterior chamber cells and flare higher than 3+ for more than 1 month after injection according to a classification described elsewhere ; 2) decrease in CMT more than 50um; 3)genesis of abnormal tissues (teratomas) or tumors; 4) qualitative changes in retinal or choroidal perfusion, like macular nonperfusion. Secondary outcome measures will be used to evaluate the short-term efficiency of intravitreal of ABMDSC: 1) improvement in ERG response; 2) increase in visual field: 3) increase in CSMT \\> 50um and not related to macular edema; 4) increase \\> 5 letters on BCVA'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of retinitis pigmentosa\n* logarithm of minimum angle of resolution (logMAR) BCVA of 1.0 (Snellen equivalent, 20/200) or worse\n\nExclusion Criteria:\n\n* previous ocular surgery other than cataract\n* presence of cataract or other media opacity that would influence ocular fundus documentation and adequate ERG and visual field evaluation\n* other ophthalmic disease like glaucoma and uveitis\n* previous history of blood disorders like leukemia\n* known allergy to fluorescein or indocyanine green\n* known coagulation abnormalities or current use of anticoagulative medication other than aspirin.'}, 'identificationModule': {'nctId': 'NCT01068561', 'briefTitle': 'Autologous Bone Marrow-Derived Stem Cells Transplantation For Retinitis Pigmentosa', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Phase 1 Study Of Autologous Bone Marrow-Derived Stem Cells Transplantation For Retinitis Pigmentosa', 'orgStudyIdInfo': {'id': 'CPRS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test group', 'description': 'open-label study of retinitis pigmentosa patients with best-corrected visual acuity (BCVA) worse than 20/200.', 'interventionNames': ['Biological: intravitreal injection of autologous bone marrow stem cells']}], 'interventions': [{'name': 'intravitreal injection of autologous bone marrow stem cells', 'type': 'BIOLOGICAL', 'otherNames': ['Autologous bone marrow mononuclear stem cells'], 'description': 'One intravitreal injection of a 0.1-ml cell suspension containing around 10x106 bone marrow mononuclear stem cells(BMMSC). All treatments were performed by a single retinal specialist using topical proparacaine drops under sterile conditions (eyelid speculum and povidone-iodine). Autologous BMMSC were injected into the vitreous cavity using a 27 gauge needle inserted through the inferotemporal pars plana 3.0 - 3.5 mm posterior to the limbus. After the injection, central retinal artery perfusion was confirmed with indirect ophthalmoscopy. Patients were instructed to instill one drop of 0.3% ciprofloxacin into the injected eye four times daily for 1 week after the procedure.', 'armGroupLabels': ['Test group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15010-100', 'city': 'São Jose Do Rio Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'CPRS'}], 'overallOfficials': [{'name': 'Rubens C Siqueira, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Center Rubens Siqueira,Catanduva Medicine School and São Paulo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD,PhD', 'investigatorFullName': 'Rubens Camargo Siqueira', 'investigatorAffiliation': 'University of Sao Paulo'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-11-18', 'type': 'RELEASE'}, {'date': '2014-01-09', 'type': 'RESET'}, {'date': '2014-01-12', 'type': 'RELEASE'}, {'date': '2014-03-03', 'type': 'RESET'}, {'date': '2017-07-18', 'type': 'RELEASE'}, {'date': '2018-02-01', 'type': 'RESET'}, {'date': '2018-10-15', 'type': 'RELEASE'}, {'date': '2019-02-19', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Rubens Camargo Siqueira, MD,PhD, University of Sao Paulo'}}}}