Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT05187104
Status:
UNKNOWN
Last Update Posted:
2022-09-14
First Post:
2021-12-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Age-related Macular Degeneration Using Retinal Stem and Progenitor Cells
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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-09', 'studyFirstSubmitDate': '2021-12-24', 'studyFirstSubmitQcDate': '2021-12-24', 'lastUpdatePostDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': '1 month', 'description': 'Determination of visual acuity after the therapy'}, {'measure': 'Visual acuity', 'timeFrame': '1 year', 'description': 'Determination of visual acuity after the therapy'}, {'measure': 'Adverse effects associated with the therapy', 'timeFrame': '1 month', 'description': 'Determination of adverse effects associated with the therapy'}, {'measure': 'Adverse effects associated with the therapy', 'timeFrame': '1 year', 'description': 'Determination of adverse effects associated with the therapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Age-Related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'Treatment of age-related macular degeneration using retinal stem and progenitor cells', 'detailedDescription': 'The aim of the project is to develop a biomedical cell product based on retinal pigment epithelium cells for highly effective treatment age-related macular degeneration; to conduct the clinical trials of the biomedical cell product in the treatment of age-related macular degeneration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of age-related macular degeneration\n* The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation\n* Written informed consent\n\nExclusion Criteria:\n\n* The presence of any malignant tumor within the last 5 years\n* Acute or chronic diseases in the stage of decompensation\n* Chronic infectious diseases: HIV, viral hepatitis B, C, tuberculosis\n* Patients who are pregnant, breastfeeding, or fertile patients who are not using adequate contraceptive methods\n* Chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol\n* Patients are unable or unwilling to give written informed consent and / or follow research procedures\n* Any other medical condition that, in the opinion of the investigator, may be associated with an increased risk to the patient or may affect the outcome or evaluation of the study'}, 'identificationModule': {'nctId': 'NCT05187104', 'briefTitle': 'Treatment of Age-related Macular Degeneration Using Retinal Stem and Progenitor Cells', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus'}, 'officialTitle': 'Treatment of Age-related Macular Degeneration Using Retinal Stem and Progenitor Cells', 'orgStudyIdInfo': {'id': 'IBCE_Retinal'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with age-related macular degeneration receiving standard treatment and retinal stem cells', 'description': 'Patients with age-related macular degeneration receiving standard treatment and autologous retinal stem and progenitor cells', 'interventionNames': ['Biological: Cultured retinal stem and progenitor cells', 'Other: Standard treatment according to the clinical protocols']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patients with age-related macular degeneration receiving standard treatment', 'description': 'Patients with age-related macular degeneration receiving standard treatment', 'interventionNames': ['Other: Standard treatment according to the clinical protocols']}], 'interventions': [{'name': 'Cultured retinal stem and progenitor cells', 'type': 'BIOLOGICAL', 'description': 'Cultured retinal stem and progenitor cells injected subretinally', 'armGroupLabels': ['Patients with age-related macular degeneration receiving standard treatment and retinal stem cells']}, {'name': 'Standard treatment according to the clinical protocols', 'type': 'OTHER', 'description': 'Standard treatment of age-related macular degeneration according to the clinical protocols', 'armGroupLabels': ['Patients with age-related macular degeneration receiving standard treatment', 'Patients with age-related macular degeneration receiving standard treatment and retinal stem cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '220072', 'city': 'Minsk', 'country': 'Belarus', 'facility': 'Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}], 'overallOfficials': [{'name': 'Ludmila Marchenko, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Belarusian State Medical University'}, {'name': 'Zinaida Kvacheva, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Belarusian State Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}