Ignite Creation Date:
2025-12-24 @ 2:34 PM
Ignite Modification Date:
2025-12-25 @ 1:06 PM
Study NCT ID:
NCT01736059
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-07
First Post:
2012-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Autologous Intravitreal Bone-marrow CD34+ Stem Cells for Retinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}, {'id': 'D012174', 'term': 'Retinitis Pigmentosa'}, {'id': 'D012164', 'term': 'Retinal Diseases'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D058499', 'term': 'Retinal Dystrophies'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-03', 'studyFirstSubmitDate': '2012-07-25', 'studyFirstSubmitQcDate': '2012-11-21', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence and severity of systemic adverse events', 'timeFrame': '1 day to 6 months', 'description': 'Any systemic adverse event attributable to the bone marrow aspiration or intravitreal injection of the stem cells.'}], 'primaryOutcomes': [{'measure': 'Incidence and severity of ocular adverse events', 'timeFrame': '1 day to 6 months', 'description': 'As evident on eye examination by severe decrease in vision and/or adverse effect requiring major treatment intervention directly attributable to study treatment.'}], 'secondaryOutcomes': [{'measure': 'The number of stem cells isolated and injected into the study eye', 'timeFrame': '1 day', 'description': 'Will determine the yield of the bone marrow aspiration and stem cell isolation procedures.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stem cells', 'intravitreal', 'bone marrow CD34+ cells', 'retinal disease', 'clinical trial', 'autologous'], 'conditions': ['Non-exudative Age-related Macular Degeneration', 'Diabetic Retinopathy', 'Retina Vein Occlusion', 'Retinitis Pigmentosa', 'Hereditary Macular Degeneration']}, 'referencesModule': {'references': [{'pmid': '27116667', 'type': 'BACKGROUND', 'citation': 'Park SS. Cell Therapy Applications for Retinal Vascular Diseases: Diabetic Retinopathy and Retinal Vein Occlusion. Invest Ophthalmol Vis Sci. 2016 Apr 1;57(5):ORSFj1-ORSFj10. doi: 10.1167/iovs.15-17594.'}, {'pmid': '25491299', 'type': 'RESULT', 'citation': 'Park SS, Bauer G, Abedi M, Pontow S, Panorgias A, Jonnal R, Zawadzki RJ, Werner JS, Nolta J. Intravitreal autologous bone marrow CD34+ cell therapy for ischemic and degenerative retinal disorders: preliminary phase 1 clinical trial findings. Invest Ophthalmol Vis Sci. 2014 Dec 9;56(1):81-9. doi: 10.1167/iovs.14-15415.'}], 'seeAlsoLinks': [{'url': 'https://studypages.com/s/innovative-stem-cell-study-for-serious-vision-loss-at-uc-davis-eye-center-906754/', 'label': 'Learn more or sign up for the study here!'}]}, 'descriptionModule': {'briefSummary': 'This pilot study is to determine whether it would be safe and feasible to inject CD34+ stem cells from bone marrow into the eye as treatment for patients who are irreversibly blind from various retinal conditions.', 'detailedDescription': 'In this pilot clinical trial, eyes with irreversible vision loss from retinal degenerative conditions (macular degeneration or retinitis pigmentosa) or retinal vascular disease (diabetic retinopathy or retinal vein occlusion) will be treated with intravitreal injection of autologous CD34+ stem cells isolated from bone marrow aspirate under Good Manufacturing Practice conditions. This study will determine whether there are any major safety and feasibility concerns using this therapy. Patients will be followed for 6 months after treatment by serial comprehensive eye examination supplemented with various retinal imaging and diagnostic tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>18 years of age\n* visual acuity 20/100 to CF\n* duration of vision loss \\> 3 months\n* vision loss from macular degeneration, retinitis pigmentosa, retinal vein occlusion or diabetic retinopathy\n* the study eye has the worse visual acuity\n* no active eye or systemic disease\n* no history of macular edema or retinal/choroidal neovascularization requiring treatment within 6 months\n* no significant media opacity\n* no coagulopathy or other hematologic abnormality\n* no concurrent immunosuppressive therapy\n* able to keep follow-up for 6 months\n\nExclusion Criteria:\n\n* allergy to fluorescein dye\n* other concurrent retinal or optic nerve disease affecting vision'}, 'identificationModule': {'nctId': 'NCT01736059', 'briefTitle': 'Clinical Trial of Autologous Intravitreal Bone-marrow CD34+ Stem Cells for Retinopathy', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'A Pilot Clinical Trial of the Feasibility and Safety of Intravitreal Autologous Adult Bone Marrow Stem Cells in Treating Eyes With Vision Loss From Retinopathy', 'orgStudyIdInfo': {'id': '906595'}, 'secondaryIdInfos': [{'id': 'BMSCRetPilot', 'type': 'OTHER', 'domain': 'Other'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stem cell treated', 'interventionNames': ['Drug: CD34+ bone marrow stem cells intravitreal']}], 'interventions': [{'name': 'CD34+ bone marrow stem cells intravitreal', 'type': 'DRUG', 'armGroupLabels': ['Stem cell treated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Susanna s Park, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California Davis Eye Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Once study is completed, the study findings will be published in peer reviewed publication for public access.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}