Type 2 Diabetes With Renal Manifestations
Conditions
Keywords
human umbilical cord mesenchymal stem cells, type 2 diabetic nephropathy
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.
Interventions
BIOLOGICALhuman umbilical cord mesenchymal stem cells
human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group
OTHERsaline
Saline solution containing human serum albumin will be infused to the control group
Sponsors
Chinese PLA General Hospital
Shanghai East Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| UACR | 48weeks after treatment | urinary albumin creatinine ratio |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 48weeks after treatment | HbA1c |
| insulin/C peptide | 48weeks after treatment | serum level of insulin/C peptide |
| insulin dosage | 48weeks after treatment | insulin dosage |
| eGFR | 48weeks after treatment | estimated glomerular filtration rate |
Countries
China
Contacts
Primary ContactCongrong Wang, MD
Backup ContactZhongming Liu, MD
Outcome results
None listed