diabetic nephropathy
Conditions
Interventions
Case series:injection of human umbilical cord mesenchymal stem cells
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 70 years male and female; 2. Comply with WHO 1999 diagnostic criteria for type 2 diabetes; 3. 19 kg/m2 = body mass index (BMI) = 30 kg/m2; 4. There is evidence of clinical kidney damage, at least one of the following three: (1) microalbuminuria (urinary albumin creatinine ratio of 30-300 mg/g Cr); (2) dominant proteinuria (urinary albumin creatinine ratio = 300mg/g Cr); (3) eGFR decreased (30mL/(min/1.73m2) = eGFR <60mL/(min/1.73m2)) (calculated according to the MDRD formula). At the same time, the clinical consideration is diabetic kidney disease (DKD), which has at least one of the following three: (1) The duration of diabetes is more than 10 years; (2) there is diabetic retinopathy; (3) Exclude chronic kidney disease caused by non-diabetes. 5. At least a stable dose of angiotensin-converting enzyme inhibitor (ACEI) or angiotensin II receptor antagonist (ARB) drug treatment before = 3 months; 6. Glycated hemoglobin (HbA1c) at the time of screening 6.5%~10% (inclusive); 7. Voluntarily participate in this clinical study and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Non-type 2 diabetes. 2. There were severe acute complications of diabetes within 6 months before screening, such as diabetic ketoacidosis, lactic acidosis or hyperglycemia and hyperosmolarity. 3. In the 6 months prior to screening, severe hypoglycemia (blood sugar = 3.9mmol/L and need to be assisted by others) occurred. 4. Definitely diagnosed as other kidney diseases (such as polycystic kidney disease, lupus kidney injury, kidney damage caused by hepatitis B, etc.) or consider non-diabetic chronic kidney disease (CKD): (1) no diabetic retinopathy; (2) GFR is lower or Rapid decline; (3) proteinuria increased or nephrotic syndrome; (4) refractory hypertension; (5) urine sediment examination activity; (6) other systemic disease symptoms or signs; (7) ACEI or ARB drugs started treatment 2 to 3 months The intra-renal glomerular filtration rate decreased by more than 30%. 5. The kidney has one of the following conditions: (1) have been or are preparing for a kidney transplant; (2) need renal replacement therapy (including hemodialysis, peritoneal dialysis, bedside hemofiltration, etc.): carried out within 3 months before screening; currently in progress; or ready to be carried out in the next 3 months; (3) large amount of proteinuria: 24-hour urine protein quantitation = 3.5 g; (4) eGFR < 30 mL / (min / 1.73 m2). 6. There are ocular diseases confirmed by ophthalmologists that require treatment in the near term (within 3 months), including but not limited to diabetic retinopathy; 7. There were severe cardiovascular and cerebrovascular diseases: a history of decompensated cardiac insufficiency (NYHA grade III or IV), myocardial infarction or cerebral infarction occurred within 6 months before screening; 8. Uncontrolled hypertension: systolic blood pressure =180 mmHg and/or diastolic blood pressure =100 mmHg at screening; or hypertensive encephalopathy occurred within 6 months before screening; 9. Those with abnormal liver function (ALT and/or AST = 2.5 times the upper limit of normal value); 10. HIV antibody, hepatitis B surface antigen, hepatitis C antibody, and syphilis test positive; 11. Consolidation of other serious systemic diseases affecting research, including malignant tumors, nervous system, blood system, digestive system, endocrine system, respiratory system, infectious diseases, etc.; 12. Drug abuse, alcohol abuse or drug abusers; 13. Pregnancy and lactating women; pregnancy plans (including maternal pregnancy) in the next six months; refusal to take effective contraceptive measures; 14. Those who are known or suspected to be allergic to the study drug and its components; 15. Those who have used stem cell therapy or have participated in clinical research on stem cells; those who have participated in drug clinical research within 3 months before screening; 16. There are other circumstances in which the investigator considers it inappropriate to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serological examination;chest radiography;Blood Routine;Urine Routine;Liver Function Tests; | — |
Countries
China
Contacts
Public ContactTianpei Hong
Peking University Third Hospital
Outcome results
None listed