Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT06731192
Eligibility Criteria:
Inclusion Criteria:
* 3 years old ≤Age ≤ 12 years old;
* 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:
* Age \<3 years or \>12 years old;
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
12 Years
Study:
NCT06731192
Study Brief:
Protocol Section:
NCT06731192