Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT01539902
Status:
UNKNOWN
Last Update Posted:
2012-03-06
First Post:
2012-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 2 Study of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008181', 'term': 'Lupus Nephritis'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-05', 'studyFirstSubmitDate': '2012-02-22', 'studyFirstSubmitQcDate': '2012-02-22', 'lastUpdatePostDateStruct': {'date': '2012-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy and Safety', 'timeFrame': '6 months', 'description': 'The efficacy measure is remission of nephritis (combined partial and complete remission) at 6 months defined as\n\n* Stabilization or improvement in renal function and\n* Urinary RBC of less than 10 per HPF and\n* Reduction of proteinuria to less than 3 g/day if baseline proteinuria was more than 3 g/day and at least a 50% reduction in proteinuria, or to less than 1 g/day if the baseline proteinuria was in the subnephrotic range.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['MSC for the treatment of Lupus Nephritis'], 'conditions': ['Lupus Nephritis']}, 'referencesModule': {'references': [{'pmid': '28478399', 'type': 'DERIVED', 'citation': 'Deng D, Zhang P, Guo Y, Lim TO. A randomised double-blind, placebo-controlled trial of allogeneic umbilical cord-derived mesenchymal stem cell for lupus nephritis. Ann Rheum Dis. 2017 Aug;76(8):1436-1439. doi: 10.1136/annrheumdis-2017-211073. Epub 2017 May 6.'}]}, 'descriptionModule': {'briefSummary': 'The efficacy measure of hUC-MSC in the treatment of proliferative lupus nephritis on remission of lupus nephritis (combined partial and complete remission) in terms of stabilization and improvement in renal function.', 'detailedDescription': 'Inclusion criteria:\n\n1. Male or non-pregnant females age 16 to 65 years inclusive.\n2. Written informed consent obtained from patient or parents/guardian.\n3. Patients with SLE fulfilling American Rheumatism Association criteria and SLEDAI score\\>8 or BILAG score A/B.\n4. Patients with newly diagnosed World Health Organization (WHO) Class III or IV Lupus Nephritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or non-pregnant females age 16 to 65 years inclusive.\n2. Written informed consent obtained from patient or parents/guardian.\n3. Patients with SLE fulfilling American Rheumatism Association criteria and SLEDAI score\\>8 or BILAG score A/B.\n4. Patients with newly diagnosed World Health Organization (WHO) Class III or IV Lupus Nephritis\n\nExclusion Criteria:\n\nPatients with any of the following are not eligible for enrollment into the study:\n\n1. Pregnant or nursing woman or women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having negative pregnancy test.\n2. Participation in any research in which the patient received an investigational product within 30 days preceding the screening phase of this study.\n3. Those persons directly involved in the conduct of the study.\n4. Serum creatinine more than 250 µmol/L.\n5. White blood cell (WBC) count of less than 3.5 X 109/L.\n6. Active peptic ulcer disease.\n7. Active systemic infection.\n8. History of alcohol or substance abuse.\n9. History of malignancy within previous 5 years.\n10. Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study.'}, 'identificationModule': {'nctId': 'NCT01539902', 'acronym': 'hUC-MSC-SLE', 'briefTitle': 'Phase 2 Study of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis', 'organization': {'class': 'OTHER', 'fullName': 'CytoMed & Beike'}, 'officialTitle': 'A Randomized, Double Blind, Parallel Group, Placebo Controlled Research of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis', 'orgStudyIdInfo': {'id': 'CT 11-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Human Umbilical Cord derived MSCs', 'interventionNames': ['Biological: Human Umbilical Cord derived MSCs']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cyclophosphamide', 'interventionNames': ['Drug: Cyclophosphamide']}], 'interventions': [{'name': 'Human Umbilical Cord derived MSCs', 'type': 'BIOLOGICAL', 'otherNames': ['Allogeneic stem cells derived from umbilical cord'], 'description': 'Human Umbilical Cord derived MSCs treatment for lupus nephritis via infusion', 'armGroupLabels': ['Human Umbilical Cord derived MSCs']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Immunosupressive agent'], 'description': 'Cyclophosphamide based immunosuppressive agent for treatment for lupus nephritis', 'armGroupLabels': ['Cyclophosphamide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '650000', 'city': 'Kunming', 'state': 'Yunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'PeiLian Zhang, Dr', 'role': 'CONTACT', 'email': 'mzczpl1968@163.com'}, {'name': 'DanQi Deng, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'PeiLian Zhang, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Second Affiliated Hospital & SLE Research Centre, Kunming Medical University, Kunming China', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CytoMed & Beike', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}