Diabetic Nephropathy
Conditions
Keywords
Diabetic Nephropathy, Safety, Efficiency, Cell Therapy, UC-MSCs
Brief summary
Diabetic nephropathy (DN) is one of the most serious complications of diabetes and the leading cause of end-stage chronic kidney disease. DN is a refractory disease with low awareness, high incidence, and high disability. The incidence of DN can reach 30 to 40% after 20 years of diabetes, of which 5\ 10% of patients will progress to end-stage renal disease, and epidemiological surveys predict that by 2030, DN will become the seventh leading cause of death in the world. Currently, there are no effective drugs for treating DN. This clinical trial is to inspect the safety and efficiency of human umbilical cord mesenchymal stem cells (UC-MSCs) therapy for patients with DN.
Detailed description
Diabetic nephropathy (DN) is one of the most important microvascular complications of diabetes. It is a persistent and refractory disease. There is currently a lack of effective clinical treatments for DN. The basic pathological processes of DN are renal tissue cell damage, apoptosis and continuous increase of inflammatory cytokines induced by early high glucose, which gradually leads to glomerular sclerosis and renal fibrosis. Human umbilical cord mesenchymal stem cells (UC-MSCs), as the youngest adult stem cells, have powerful anti-inflammatory functions, stronger differentiation potential, and good safety. They are ideal seed cells for the treatment of DN. At present, studies on a variety of animal models of DN have shown that mesenchymal stem cell transplantation can delay the progression of DN and have a certain repair effect on damaged kidney tissue and renal function. Our previous preclinical study showed that UC-MSCs effectively improved the renal function, inhibited inflammation and fibrosis, and prevented its progression in a rat model of diabetes-induced chronic renal injury. Some autologous or allogeneic mesenchymal stem cells have been carried out abroad treatment of chronic kidney disease caused by various reasons, including clinical trials of DN, phase I/II test results did not show obvious adverse reactions related to stem cell therapy, and can improve the patient's renal function and quality of life to a certain extent. The purpose of this study is to investigate efficiency and safety of UC-MSCs in treating DN patients. This trial will recruit 38 patients. 19 patients received the treatment of conventional treatment + equal volume normal saline containing 1% human albumin (placebo group) were used as control group; conventional treatment + 1\*10E6 UC-MSCs/kg body weight (experimental group) for intravenous infusion (once a week, 3 times in total) to treat 19 patients with DN (by unified standard inclusion), and subjects will be followed a total of 48 weeks from time of initial cell treatment.
Interventions
DRUGUC-MSCs
3 times of UC-MSCs (1\*10E6 UC-MSCs/kg body weight/100mL saline containing 1% human albumin intravenously at week 1,week 2, week 3).
DRUGPlacebo
3 times of cell-free stem cell suspension (saline containing 1% human albumin/100mL intravenously at week 1, week 2, week 3).
Sponsors
Wuhan Hamilton Biotechnology Co., Ltd
Renmin Hospital of Wuhan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Type 2 diabetes mellitus, course 5-15 years; 2. Age 30-65 years old, no gender limit; 3. Accompanied by proteinuria, urine albumin/creatinine ratio (UACR)\>300mg/g or 24h urine protein quantitative\>0.5g/24h; 4. eGFR is between 30-60 ml/min/1.732 m2; 5. Take RASI-based antihypertensive drugs to control blood pressure and blood pressure meets the following standards: systolic blood pressure \<150mmHg, and diastolic blood pressure \<100mmHg; 6. Blood lipids and blood uric acid are controlled at appropriate levels; 7. The pathological diagnosis of kidney biopsy is diabetic nephropathy; 8. Patients who have good compliance, signed informed consent, and can complete the entire trial treatment and follow-up plan according to the research plan； 9. No
Exclusion criteria
are positive.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | From Baseline (0 W) to 48 weeks after treatment | The number of Adverse Events associated with UC-MSCs intervention per treatment arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kidney function | From Baseline (0 W) to 48 weeks after treatment | Change in estimated glomerular filtration rate (eGFR) from baseline. |
| SF-36 (The MOS item short from health survey) | From Baseline (0 W) to 48 weeks after treatment | The MOS item short from health survey, SF-36 and changes per visit. As a concise health questionnaire, SF-36 comprehensively summarizes the quality of life of the surveyed from 8 aspects: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. Higher scores mean a better outcome. |
| Change in HbA1c | From Baseline (0 W) to 48 weeks after treatment | Change in Glycosylated Hemoglobin (HbA1c) from baseline. |
Countries
China
Contacts
Primary ContactHuiming Wang, MD
Backup ContactYujuan Wang, MD
Outcome results
None listed