Human Umbilical Cord Mesenchymal Stem Cells for Alport Syndrome

Last updated: December 29, 2024
Sponsor: Guangzhou Women and Children's Medical Center
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Nephritis

Nephropathy

Kidney Failure

Treatment

Placebo control drug

hUC-MSC

Clinical Study ID

NCT06731192
[2022]00100-3
MR-44-24-042448
  • Ages 3-12
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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, glomerularfiltration 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

Exclusion Criteria:

  • Age <3 years or >12 years old;

  • Alport syndrome patients with only microscopic hematuria and normal glomerularfiltration rate;

  • Patients with significantly reduced renal function, chronic kidney disease stage IVor V, Alport syndrome;

  • Patients with other renal diseases;

  • Have a history of severe allergic reactions or be allergic to 2 or more foods ordrugs;

  • Known allergy to stem cells or stem cell-derived products or ingredients in stemcell 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.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Placebo control drug
Phase: 2/3
Study Start date:
January 01, 2025
Estimated Completion Date:
December 31, 2028