Human Umbilical Cord Mesenchymal Stem Cells for Alport Syndrome
NCT ID: NCT06731192
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2/PHASE3
40 participants
INTERVENTIONAL
2025-01-01
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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MSC Theatment
Conventional symptomatic supportive treatment and human umbilical cord mesenchymal stem cells treatment
hUC-MSC
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.
Conventional clinical treatment refers to symptomatic treatment with ACEI and ARB drugs.
Placebo Control
Conventional symptomatic supportive treatment and normal saline as a placebo control
Placebo control drug
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.
Conventional clinical treatment refers to symptomatic treatment with ACEI and ARB drugs.
Interventions
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hUC-MSC
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.
Conventional clinical treatment refers to symptomatic treatment with ACEI and ARB drugs.
Placebo control drug
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.
Conventional clinical treatment refers to symptomatic treatment with ACEI and ARB drugs.
Eligibility Criteria
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Inclusion Criteria
* Meet the diagnostic criteria of Alport syndrome;
* Positive proteinuria or combined hematuria;
* Chronic kidney disease (CKD) stage: I-III stage children, that is, glomerular filtration rate greater than 60 ml/min.1.73m2;
* No history of infectious diseases within 1 week before treatment;
* Negative infectious disease screening;
* No allergic state and related clinical manifestations;
* Signed informed consent (children or their families).
Exclusion Criteria
* Alport syndrome patients with only microscopic hematuria and normal glomerular filtration rate;
* Patients with significantly reduced renal function, chronic kidney disease stage IV or V, Alport syndrome;
* Patients with other renal diseases;
* Have a history of severe allergic reactions or be allergic to 2 or more foods or drugs;
* Known allergy to stem cells or stem cell-derived products or ingredients in stem cell preparations;
* Have severe heart, liver, lung and other organ dysfunction or have tumors;
* Those with developmental malformations of the urinary system;
* Those with autoimmune diseases and regular use of immunosuppressants;
* Those with serious infectious diseases that are not under control;
* Those with a history of infectious diseases such as HBV, HCV, HIV, syphilis;
* History of surgery or acute trauma or blood loss exceeding 200ml within 3 months;
* Participated in other clinical studies within 3 months;
* Have received any cell product or derivative product treatment within 12 months;
* Other circumstances that the researcher deems inappropriate for inclusion.
3 Years
12 Years
ALL
No
Sponsors
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Guangzhou Women and Children's Medical Center
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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MR-44-24-042448
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
[2022]00100-3
Identifier Type: -
Identifier Source: org_study_id