Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-03-01 @ 9:59 AM
Study NCT ID:
NCT02749734
Status:
UNKNOWN
Last Update Posted:
2018-01-31
First Post:
2016-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of Subretinal Transplantation of Human Embryo Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Macular Degeneration Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2024-09-18', 'unreleaseDate': '2024-09-22'}, {'releaseDate': '2024-09-22', 'unreleaseDate': '2024-09-29'}, {'resetDate': '2024-11-21', 'releaseDate': '2024-09-29'}, {'resetDate': '2025-01-31', 'releaseDate': '2025-01-05'}], 'estimatedResultsFirstSubmitDate': '2024-09-18'}}, '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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-29', 'studyFirstSubmitDate': '2016-01-07', 'studyFirstSubmitQcDate': '2016-04-20', 'lastUpdatePostDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Treatment-Related Adverse Events [Safety and Tolerability]', 'timeFrame': 'up to 12 months', 'description': 'Patients with Treatment-Related Adverse Events caused by local rejection of implanted cells or systemic immunosuppression treatment'}], 'secondaryOutcomes': [{'measure': 'Number of Early Treatment Diabetic Retinopathy (ETDR ) letters participants can recognize', 'timeFrame': 'up to 12 months', 'description': 'Visual acuity is reflected by number of ETDR letters participants can recognize'}, {'measure': 'Visual Field as examined by Static perimetry', 'timeFrame': 'up to 12 months', 'description': 'Area and sensitivity of visual field are detected by Static perimetry'}, {'measure': 'Flash Electroretinogram (FERG)', 'timeFrame': 'up to 12 months', 'description': 'Retinal electrophysiological function is tested by FERG'}, {'measure': 'Amplitude and Latency of Flash Visual Evoked Potentials (FVEP)', 'timeFrame': 'up to 12 months', 'description': 'Optic nerve function as assessed by FVEP'}, {'measure': 'Multifocal Electroretinogram (MFERG)', 'timeFrame': 'up to 12 months', 'description': 'Local retinal function as assessed by MFERG'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Human embryo stem cell derived retinal pigment epitheliums', 'Subretinal transplantation', 'Wet Age related Macular degeneration', "Stargardt's macular dystrophy"], 'conditions': ['Macular Degeneration', "Stargardt's Macular Dystrophy"]}, 'referencesModule': {'references': [{'pmid': '40020685', 'type': 'DERIVED', 'citation': 'Lv YX, Li QY, Duan P, Zhang MF, Liu B, Li SY, Zhao TT, Wang H, Liu Y, Yin ZQ. Safe CNV removal is crucial for successful hESC-RPE transplantation in wet age-related macular degeneration. Stem Cell Reports. 2025 Mar 11;20(3):102424. doi: 10.1016/j.stemcr.2025.102424. Epub 2025 Feb 27.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study was to determine the safety and therapeutic effect of sub-retinal transplantation of human embryo stem cell derived retinal pigment epitheliums (hESC-RPE) in patients with macular degeneration diseases, and explore new treatment modalities for macular degeneration diseases (Age-related macular degeneration and Stargardt's macular dystrophy)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aging from 18 to 75 years\n* must have signed informed consent\n* At least one visually impaired eye caused by macular degeneration diseases\n* Can not be effectively treated with conventional therapies\n* Best corrected visual acuity scores between 19 and 73 letter in ETDRs (early treatment diabetic retinopathy ) eye chart , including 19 and 73 (or the equivalent of Snellen eyesight from 20/400 to 20/40)\n* Visual loss caused by macular degeneration diseases\n\nExclusion Criteria:\n\n* Eyes with concomitant diseases which will interfere the visual improvement of the study\n* Active intraocular inflammation regardless of the grade of severity\n* Active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, ophthalmia)\n* History of uveitis\n* Severe cataract, glaucoma, retinal blood vessels occlusion, retinal detachment, macular hole, vitreous-macula traction\n* Iris neovascularization\n* Patients who have only one functioning eye, or the best corrected vision of untreated eye scores less than 24 letters in ETDRS chart(corresponding to 20/320 in Snellen chart)\n* History of intraocular surgery\n* Severe systemic diseases: Stroke, coronary heart disease, angina pectoris, renal insufficiency needing dialysis\n* Allergic to sodium fluorescein\n* Uncontrolled hypertension (systolic pressure\\>140mmHg,or diastolic pressure\\>90mmHg)\n* Coagulative function disorder\n* System administration of drugs that are toxic to lens, retina, or optic nerve like hydroxychloroquine, phenothiazine, ethambutol, tamoxifen, etc.\n* Involved in other clinical trials of any medicine within 1 month (or within 5 half-life periods)\n* Have maternity plan in 6 months\n* In pregnancy or lactation period.'}, 'identificationModule': {'nctId': 'NCT02749734', 'briefTitle': 'Clinical Study of Subretinal Transplantation of Human Embryo Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Macular Degeneration Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Southwest Hospital, China'}, 'officialTitle': 'Clinical Study of Subretinal Transplantation of Human Embryo Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Macular Degeneration Diseases', 'orgStudyIdInfo': {'id': '2013CB967002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hESC-RPE', 'description': 'Subretinal transplantation of Human embryo stem cell derived retinal pigment epitheliums', 'interventionNames': ['Procedure: Subretinal transplantation']}], 'interventions': [{'name': 'Subretinal transplantation', 'type': 'PROCEDURE', 'description': 'Transplant hESC-RPE into subretinal space of patients with macular degeneration', 'armGroupLabels': ['hESC-RPE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400038', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Southwest Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southwest Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'ZhengQin Yin', 'investigatorAffiliation': 'Southwest Hospital, China'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-09-18', 'type': 'RELEASE'}, {'date': '2024-09-22', 'type': 'UNRELEASE'}, {'date': '2024-09-22', 'type': 'RELEASE'}, {'date': '2024-09-29', 'type': 'UNRELEASE'}, {'date': '2024-09-29', 'type': 'RELEASE'}, {'date': '2024-11-21', 'type': 'RESET'}, {'date': '2025-01-05', 'type': 'RELEASE'}, {'date': '2025-01-31', 'type': 'RESET'}], 'unpostedResponsibleParty': 'ZhengQin Yin, Professor, Southwest Hospital, China'}}}}