Albuminuria in the patients with Alport syndrome Urological and Genital Diseases
Conditions
Interventions
hUC-MSCs will be injected intravenously at a dose of 20 × 10e6 cells. The duration of infusion will last for 20 - 30 min. Patients will receive four doses of hUC-MSC at an interval of 7 days.
Sponsors
Science and Technology Department of Hubei Province
Eligibility
Sex/Gender
All
Age
3 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with Alport syndrome (AS) according to the diagnosis criteria 2. Aged 3-18 years 3. Hematuria or combination with albuminuria persisted without remission after routine treatments for 1 year 4. Chronic kidney disease stage I-III, glomerular filtration rate >60 ml/min.1.73 m² 5. Written informed consent is obtained before study specific procedure
Exclusion criteria
Exclusion criteria: 1. Aged >18 years 2. Creatinine clearance rate <30 ml/min, or chronic kidney disease stage IV-V 3. With one of the disease histories: immunological disease or autoimmune diseases; serious hematologic or coagulation disorder; urogenital abnormalities; malignancy history; congenital heart disease or serious cardiovascular, liver, or pulmonary dysfunction 4. Uncontrolled endocrine diseases (e.g. diabetes, hyperthyroidism) 5. Serious allergy history or known allergy to more than two kinds of foods or medications 6. Active systemic infection 7. Any other concerns that hampered compliance or safety as judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Adverse event incidence is calculated at baseline (Day 0), weekly in the treatment phase (Day 7, Day 14, Day 21), and monthly in a follow-up phase (Month 1-12 post-treatment) 2. Urine protein is tested in the laboratory at baseline (Day 0), weekly in the treatment phase (Day 7, Day 14, Day 21), and monthly in a follow-up phase (Month 1-12 post-treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hematuria is tested in the laboratory at baseline (Day 0), weekly in the treatment phase (Day 7, Day 14, Day 21), and monthly in a follow-up phase (Month 1-12 post-treatment) 2. Creatinine clearance rate is tested in the laboratory at baseline (Day 0), and monthly in a follow-up phase (Month 1-12 post-treatment) | — |
Countries
China
Outcome results
None listed