Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-02-25 @ 9:48 PM
Study NCT ID:
NCT04184258
Status:
COMPLETED
Last Update Posted:
2021-01-22
First Post:
2019-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Mesenchymal Stem Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-20', 'studyFirstSubmitDate': '2019-12-01', 'studyFirstSubmitQcDate': '2019-12-01', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy evaluation', 'timeFrame': '6 month', 'description': 'Efficacy evaluation (SELENA-SLEDAI)'}], 'secondaryOutcomes': [{'measure': 'Safety eveluation', 'timeFrame': '1 month', 'description': 'Absence of adverse reactions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Systemic Lupus Erythematosus', 'mesenchymal stem cells'], 'conditions': ['Systemic Lupus Erythematosus']}, 'descriptionModule': {'briefSummary': 'Treatment of systemic lupus erythematosus with pooled allogenic mesenchymal stem cells'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* SLE diagnosis (4 of 11 criteria by ACR);\n* positive dsDNA;\n* SELENA-SLEDAI index ≥6;\n* active lupus nephritis;\n* patient can read, understand and follow the procedures.\n\nExclusion Criteria:\n\n* need for dialysis;\n* planned renal transplantation;\n* any medical condition which can be associated with the high risk for the patient;\n* pregnancy/lactation;\n* chronic infections, including hepatitis B/C, tuberculosis, HIV;\n* any malignant tumor in the last 5 years.'}, 'identificationModule': {'nctId': 'NCT04184258', 'briefTitle': 'Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Mesenchymal Stem Cells', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus'}, 'officialTitle': 'Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Olfactory Mucosa Derived Mesenchymal Stem Cells', 'orgStudyIdInfo': {'id': 'IBCE_MSC1(SLE)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SLE patients MSC treatment', 'description': 'Patients with SLE, who receive pooled mesenchymal stem cells in addition to the standard treatment according to the Clinical protocols', 'interventionNames': ['Biological: Pooled mesenchymal stem cell', 'Other: Standard treatment according to the Clinical protocols']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SLE patients standard treatment', 'description': 'Patients with SLE, who receive standard treatment according to the Clinical protocols', 'interventionNames': ['Other: Standard treatment according to the Clinical protocols']}], 'interventions': [{'name': 'Pooled mesenchymal stem cell', 'type': 'BIOLOGICAL', 'description': 'Pooled allogenic mesenchymal stem cell derived from olfactory mucosa', 'armGroupLabels': ['SLE patients MSC treatment']}, {'name': 'Standard treatment according to the Clinical protocols', 'type': 'OTHER', 'description': 'Standard SLE treatment according to the Clinical protocols approved by the Ministry of healthcare of Republic of Belarus', 'armGroupLabels': ['SLE patients MSC treatment', 'SLE patients standard treatment']}]}, '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': 'Andrei Hancharou, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Director, the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus'}, {'name': 'Konstantin A Chizh, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Associate professor, Belarusian State Medical University'}]}, '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'}}}}