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

Phase 1
Conditions
Type 2 Diabetes With Renal Manifestations
Interventions
Biological: human umbilical cord mesenchymal stem cells
Other: saline
Registration Number
NCT04216849
Lead Sponsor
Shanghai East Hospital
Brief 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.

Detailed 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 subjects,which 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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
54
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
experimental grouphuman umbilical cord mesenchymal stem cellsThe volunteers of the experimental group will be given peripheral intravenously a dose of 1.5\*10\^6/kg human umbilical cord mesenchymal stem cells at 0,8,16,24,32 week.
control groupsalineThe control group will be given the same dose of saline containing human albumin.
Primary Outcome Measures
NameTimeMethod
UACR48weeks after treatment

urinary albumin creatinine ratio

Secondary Outcome Measures
NameTimeMethod
HbA1c48weeks after treatment

HbA1c

eGFR48weeks after treatment

estimated glomerular filtration rate

insulin/C peptide48weeks after treatment

serum level of insulin/C peptide

insulin dosage48weeks after treatment

insulin dosage

Trial Locations

Locations (1)

Shanghai East Hospital

🇨🇳

Shanghai, Shanghai, China

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