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

Study Overview
=================
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.

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

Conditions
-----------------
Type 2 Diabetes With Renal Manifestations

Intervention / Treatment
-----------------
* Biological: human umbilical cord mesenchymal stem cells
* Other: saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (in brief): Type 2 diabetes mellitus Diabetes duration≤20 years 18.5kg/m^2 ≤ BMI< 30 kg/m^2 7.5%≤HbA1C≤10% UACR≥30mg/gCr eGFR ≥45/milliliter/1.73m^2 Exclusion Criteria (in brief): Type 1 diabetes mellitus tumor history Other causes of chronic kidney disease Abnormal liver function

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>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. | Biological: human umbilical cord mesenchymal stem cells<br>* human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group<br>|
| Placebo Comparator: control group<br>The control group will be given the same dose of saline containing human albumin. | Other: saline<br>* Saline solution containing human serum albumin will be infused to the control group<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UACR | urinary albumin creatinine ratio | 48weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | HbA1c | 48weeks after treatment | 
| insulin/C peptide | serum level of insulin/C peptide | 48weeks after treatment | 
| insulin dosage | insulin dosage | 48weeks after treatment | 
| eGFR | estimated glomerular filtration rate | 48weeks after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
human umbilical cord mesenchymal stem cells, type 2 diabetic nephropathy