Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-05 @ 6:16 PM
Study NCT ID:
NCT06731192
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-31
First Post:
2024-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Umbilical Cord Mesenchymal Stem Cells for Alport Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009394', 'term': 'Nephritis, Hereditary'}], 'ancestors': [{'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-29', 'studyFirstSubmitDate': '2024-12-09', 'studyFirstSubmitQcDate': '2024-12-09', 'lastUpdatePostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urine protein remission rate', 'timeFrame': '2 weeks to 12 months after treatment', 'description': 'Follow-up was performed at 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months, 4 months, 5 months, 6 months, 8 months, 10 months, and 12 months after the last hUC-MSC infusion. Urinalysis, 24-hour urine protein quantification, and urine protein/creatinine ratio were tested to evaluate the remission of urine protein after treatment.'}], 'secondaryOutcomes': [{'measure': 'Hematuria remission rate', 'timeFrame': '2 weeks to 12 months after treatment', 'description': 'Follow-up was performed at 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months, 4 months, 5 months, 6 months, 8 months, 10 months, and 12 months after the last hUC-MSC infusion. The urine abnormal red blood cell count of the children was tested to evaluate the remission of hematuria after treatment.'}, {'measure': 'Renal function improvement rate', 'timeFrame': '2 weeks to 12 months after treatment', 'description': 'Follow-up was performed at 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months, 4 months, 5 months, 6 months, 8 months, 10 months, and 12 months after the last hUCMSC infusion to measure the serum creatinine, blood urea nitrogen, serum cystatin C, glomerular filtration rate and other indicators of the children to evaluate the improvement of renal function after treatment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alport syndrome', 'Human Umbilical Cord Mesenchymal Stem Cells', 'Randomized Clinical Trial'], 'conditions': ['Alport Syndrome']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in the treatment of Alport syndrome (AS) in a randomized, single-blind, placebo-controlled trial, to provide a clinical basis for the development of stem cell products for the treatment of AS, and to further clarify the therapeutic effect of hUC-MSC in the treatment of AS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 3 years old ≤Age ≤ 12 years old;\n* Meet the diagnostic criteria of Alport syndrome;\n* Positive proteinuria or combined hematuria;\n* Chronic kidney disease (CKD) stage: I-III stage children, that is, glomerular filtration rate greater than 60 ml/min.1.73m2;\n* No history of infectious diseases within 1 week before treatment;\n* Negative infectious disease screening;\n* No allergic state and related clinical manifestations;\n* Signed informed consent (children or their families).\n\nExclusion Criteria:\n\n* Age \\<3 years or \\>12 years old;\n* Alport syndrome patients with only microscopic hematuria and normal glomerular filtration rate;\n* Patients with significantly reduced renal function, chronic kidney disease stage IV or V, Alport syndrome;\n* Patients with other renal diseases;\n* Have a history of severe allergic reactions or be allergic to 2 or more foods or drugs;\n* Known allergy to stem cells or stem cell-derived products or ingredients in stem cell preparations;\n* Have severe heart, liver, lung and other organ dysfunction or have tumors;\n* Those with developmental malformations of the urinary system;\n* Those with autoimmune diseases and regular use of immunosuppressants;\n* Those with serious infectious diseases that are not under control;\n* Those with a history of infectious diseases such as HBV, HCV, HIV, syphilis;\n* History of surgery or acute trauma or blood loss exceeding 200ml within 3 months;\n* Participated in other clinical studies within 3 months;\n* Have received any cell product or derivative product treatment within 12 months;\n* Other circumstances that the researcher deems inappropriate for inclusion.'}, 'identificationModule': {'nctId': 'NCT06731192', 'acronym': 'HUCMSC', 'briefTitle': 'Human Umbilical Cord Mesenchymal Stem Cells for Alport Syndrome', 'organization': {'class': 'OTHER', 'fullName': "Guangzhou Women and Children's Medical Center"}, 'officialTitle': 'Human Umbilical Cord Mesenchymal Stem Cells for Alport Syndrome: Α Prospective Randomized, Single-blind, Placebo-controlled, Single-center Clinical Trial', 'orgStudyIdInfo': {'id': '[2022]00100-3'}, 'secondaryIdInfos': [{'id': 'MR-44-24-042448', 'type': 'OTHER_GRANT', 'domain': "National Health Commission of the People's Republic of China"}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MSC Theatment', 'description': 'Conventional symptomatic supportive treatment and human umbilical cord mesenchymal stem cells treatment', 'interventionNames': ['Biological: hUC-MSC']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Control', 'description': 'Conventional symptomatic supportive treatment and normal saline as a placebo control', 'interventionNames': ['Drug: Placebo control drug']}], 'interventions': [{'name': 'hUC-MSC', 'type': 'BIOLOGICAL', 'description': 'This group of patients received a total of 2 peripheral intravenous Human umbilical cord mesenchymal stem cells (hUC-MSC) infusions during the treatment period on the basis of conventional symptomatic and supportive treatment. The interval between the two infusions was 14 days, and the single infusion dose was approximately 2×1000,000 cells/Kg.\n\nConventional clinical treatment refers to symptomatic treatment with ACEI and ARB drugs.', 'armGroupLabels': ['MSC Theatment']}, {'name': 'Placebo control drug', 'type': 'DRUG', 'description': 'This group of patients received a total of 2 intravenous infusions of normal saline (the same volume, specifications and batches used in the experimental group) as a placebo control during the treatment period on the basis of conventional symptomatic and supportive treatment. The interval between the two infusions was 14 days.\n\nConventional clinical treatment refers to symptomatic treatment with ACEI and ARB drugs.', 'armGroupLabels': ['Placebo Control']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Xia Gao', 'role': 'CONTACT', 'email': 'gaoxiagz@vip.163.com', 'phone': '86-020-81330569'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangzhou Women and Children's Medical Center", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}