Clinical Study of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Type 2 Diabetic Nephropathy

  • STATUS
    Recruiting
  • participants needed
    54
  • sponsor
    Shanghai East Hospital
Updated on 3 July 2022

Summary

The study was a 48-week multicenter, randomized, double-blind, placebo-controlled trial that included 8 weeks of pre-screening and lifestyle education, 32 weeks of treatment, and 16 weeks of follow-up.To observe the efficacy and safety of umbilical cord mesenchymal stem cell infusion in Chinese patients with type 2 diabetic nephropathy who received traditional hypoglycemic therapy.

Description

The study was a 48-week multicenter, randomized, double-blind, placebo-controlled trial that included 8 weeks of pre-screening and lifestyle education, 32 weeks of treatment, and 16 weeks of follow-up.We plan to recruit 54 subjectswhich were divided into experimental group and control group. The volunteers of the experimental group will be given peripheral intravenously a dose of 1.5*10^6/kg human umbilical cord mesenchymal stem cell (HUC-MSC) at 0,8,16,24,32 week. The control group will be given the same dose of saline. Then centralization visit was conducted every 8 weeks until the 48th week.The primary end points include estimated glomerular filtration rate and urinary albumin creatinine ratio(UACR). The secondary end points include HbA1C,plasma insulin and C-peptide, and insulin dose.

Details
Condition Type 2 Diabetes With Renal Manifestations
Treatment Saline, Human umbilical cord mesenchymal stem cells
Clinical Study IdentifierNCT04216849
SponsorShanghai East Hospital
Last Modified on3 July 2022

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