Umbilical Cord Mesenchymal Stem Cells Therapy for Diabetic Nephropathy
- Conditions
- Mesenchymal Stem CellsDiabetic Nephropathy
- Interventions
- Registration Number
- NCT04125329
- Lead Sponsor
- Yan'an Affiliated Hospital of Kunming Medical University
- Brief Summary
This clinical trial assessed the safety of human umbilical cord mesenchymal stem cell therapy in 15 patients with diabetic nephropathy. Fifteen subjects received umbilical cord mesenchymal stem cell therapy 3 times. Approximately 1 × 106/kg of human umbilical cord mesenchymal stem cells were administered by peripheral intravenous infusion once a month .Endpoints:Primary endpoint: Safety and adverse events (safety and tolerability of umbilical cord mesenchymal stem cell therapy within 60 weeks).Secondary endpoint indicators:Efficacy measures: eGFR, urinary albumin-to-creatinine ratio, and percentage changes of 24-h urinary protein quantities from baseline to 60 weeks.
- Detailed Description
Dosage and administration method: Fifteen subjects received umbilical cord mesenchymal stem cell therapy 3 times. Approximately 1 × 106/kg of human umbilical cord mesenchymal stem cells were administered by peripheral intravenous infusion once a month at 0, 4, and 8 weeks. Routine medications were used.
Follow-up: Patient follow-up was performed 7 times at 0, 4, 8, 20, 32, 48, and 60 weeks. Blood and urine were collected for determination of urinary albumin-to-creatinine ratio, 24-h urine protein ratio, liver and kidney function, fasting blood glucose, 2-h postprandial blood glucose, glycosylated hemoglobin, eGFR, blood lipids, and blood electrolytes at each follow-up visit. The daily dose of insulin was recorded. Blood samples were taken after each infusion of stem cells for flow cytometry and for the detection of CD3, CD4, CD8, CD28+, Treg, CD80, CD86, HLA-DR, CD83, and CD1a cells. Plasma levels of the cytokines IFN-gamma, TNF, IL-2, IL-4, IL-10, IL-6, IL-12P70, IL-8, and IL-1 beta were also determined.
Endpoints:
Primary endpoint: Safety and adverse events (safety and tolerability of umbilical cord mesenchymal stem cell therapy within 60 weeks): The number and severity of adverse events, an evaluation of their association with the umbilical cord mesenchymal stem cell treatment, and the outcome of the adverse events.
The patients' discomfort and clinical symptoms during the study period were recorded.
The subjects' relevant laboratory test indices, 12-lead electrocardiogram, vital signs, and physical examination results were recorded during the study.
Secondary endpoint indicators:
Efficacy measures: eGFR, urinary albumin-to-creatinine ratio, and percentage changes of 24-h urinary protein quantities from baseline to 60 weeks.
Data analysis:
The number of adverse events and the number of severity adverse events were determined based on the changes in the data summary (i.e., descriptive statistics).
A multilevel statistical analysis model (mixed effects model) was used to infer the relationship between treatment factors and key indicators, reflect the changing trend of key indicators in different time periods, and draw statistical analysis conclusions.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Human umbilical cord mesenchymal stem cells Human umbilical cord mesenchymal stem cells Human umbilical cord mesenchymal stem cells were given to each diabetic nephropathy subject once a month, peripheral intravenous injection, a total of three times
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent and Treatment-Chronic Adverse Events of human umbilical cord mesenchymal stem cells for diabetic nephropathy patient 60 weeks The patient's discomfort and clinical symptoms during the study were recorded, as well as the related laboratory test indicators and physical examination abnormalities of the subjects during the study.Describe the association with umbilical cord mesenchymal stem cell therapy and calculate the incidence of treatment-related acute and chronic adverse events.
- Secondary Outcome Measures
Name Time Method Changes in eGFR before and after treatment; Changes in 24h urine protein quantification before and after treatment 60Weeks,but the major evaluated time is 12 weeks after the last treatment, compared with baseline (0W) Main evaluation index of curative effect:percentage changes in estimated glomerular filtration rate (eGFR), urinary albumin creatinine ratio, and 24-hour urinary protein quantification from baseline to 60 weeks of treatment. Other efficacy indicators included fasting blood glucose, blood glucose 2 hours after breakfast, HbA1c, blood and urine routine, liver and renal function, blood lipid, blood electrolyte, and daily insulin dosage.
Trial Locations
- Locations (1)
Yan'an Hospital of Kunming City
🇨🇳Kunming, China