Clinical Study of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Type 2 Diabetic Nephropathy
- Conditions
- Type 2 Diabetes With Renal Manifestations
- Interventions
- Biological: human umbilical cord mesenchymal stem cellsOther: 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
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description experimental group human umbilical cord mesenchymal stem cells The 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 group saline The control group will be given the same dose of saline containing human albumin.
- Primary Outcome Measures
Name Time Method UACR 48weeks after treatment urinary albumin creatinine ratio
- Secondary Outcome Measures
Name Time Method HbA1c 48weeks after treatment HbA1c
eGFR 48weeks after treatment estimated glomerular filtration rate
insulin/C peptide 48weeks after treatment serum level of insulin/C peptide
insulin dosage 48weeks after treatment insulin dosage
Trial Locations
- Locations (1)
Shanghai East Hospital
🇨🇳Shanghai, Shanghai, China