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Clinical Trial NCT06731192 (HUCMSC) for Alport Syndrome is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Human Umbilical Cord Mesenchymal Stem Cells for Alport Syndrome (HUCMSC) Phase 2, Phase 3 40 Randomized Placebo-Controlled

Not yet recruiting
Clinical Trial NCT06731192 (HUCMSC) is designed to study Treatment for Alport Syndrome. This Phase 2 Phase 3 interventional study is not yet recruiting. Enrollment is planned to begin on 1 January 2025 until the study accrues 40 participants. Led by Guangzhou Women and Children's Medical Center, this study is expected to complete by 31 December 2028. The latest data from ClinicalTrials.gov was last updated on 31 December 2024.
Brief 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.
Official Title

Human Umbilical Cord Mesenchymal Stem Cells for Alport Syndrome: Α Prospective Randomized, Single-blind, Placebo-controlled, Single-center Clinical Trial

Conditions
Alport Syndrome
Other Study IDs
  • HUCMSC
  • [2022]00100-3
  • MR-44-24-042448 (Other Grant/Funding Number) (National Health Commission of the People's Republic of China)
NCT ID Number
NCT06731192
Start Date (Actual)
2025-01-01
Last Update Posted
2024-12-31
Completion Date (Estimated)
2028-12-31
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
Phase 2
Phase 3
Status
Not yet recruiting
Keywords
Alport syndrome
Human Umbilical Cord Mesenchymal Stem Cells
Randomized Clinical Trial
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalMSC 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 ACE...Show More
Placebo ComparatorPlacebo 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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Urine protein remission rate
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.
2 weeks to 12 months after treatment
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Hematuria remission rate
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.
2 weeks to 12 months after treatment
Renal function improvement rate
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.
2 weeks to 12 months after treatment
Participation Assistant
Eligibility Criteria

Eligible Ages
Child
Minimum Age
3 Years
Eligible Sexes
All
  • 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).

  • 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.
Guangzhou Women and Children's Medical Center logoGuangzhou Women and Children's Medical Center
Study Central Contact
Contact: Xia Gao, 86-020-81330569, [email protected]
No location data.