Clinical Research of UC-MSCs in the Treatment of Diabetic Nephropathy

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Renmin Hospital of Wuhan University
• Collaborator: Wuhan Hamilton Biotechnology Co., Ltd

Criteria

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.

Exclusion Criteria:

1. Have a history of primary glomerulonephritis, lupus nephritis, ANCA-related small vasculitis, renal damage, allergic purpura nephritis, hepatitis B-related nephritis;

2. Poor blood glucose control: HbA1c ≥9% of patients or 2h postprandial blood glucose> 22mmol/L;

3. Active liver disease or liver function test results are obviously abnormal (ALT or AST ≥ 2 times the upper limit of normal);

4. White blood cell count<3.0×10E9/L, hemoglobin<80 g/L, platelet count<100×10E9/L or suffering from other blood system diseases (severe anemia, idiopathic thrombocytopenic purpura, splenomegaly, Patients with coagulopathy, etc.);

5. Severe and unstable cardiovascular and cerebrovascular diseases (unstable angina pectoris, coronary artery disease, cerebrovascular disease, transient ischemic attack, congestive heart failure, etc.), acute and uncontrollable disease, still unable to effectively control severe hypertension (blood pressure> 160/100 mmHg) after treatment or organ transplant patients;

6. The dose of antihypertensive drugs and/or hypoglycemic drugs used in the past 3 months has increased significantly than before;

7. Uncontrolled infection;

8. Suffer from tumor or abnormal level of tumor markers;

9. Suffer from blood-borne diseases (for example, HIV, syphilis, hepatitis B and hepatitis C);

10. Possibility of pregnancy, preparation for pregnancy or breastfeeding;

11. Receive immunosuppressive treatment;

12. Have a history of allergies, especially those who are allergic to human albumin;

13. Suffer from mental illness, which will affect their voluntariness, decision-making ability and communication ability;

14. A history of alcohol abuse or a known history of drug abuse in the last 2 years;

15. Participate in another clinical trial within the last 3 months;

16. Poor compliance, unable to complete the entire study；

17. The researcher diagnosed that the patient is not suitable for this study