Diabetic nephropathy
Conditions
Interventions
Control group:Normal saline + alprostadil
Test group:Normal saline + alprostadil + cord blood
Sponsors
Shandong Provincial Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent; 2. Men and women between the ages of 18 and 65 (including 18 and 65); 3. Diagnosed with type 1 or type 2 diabetes for more than 6 months according to WHO criteria (1999); 4. At screening, glycosylated hemoglobin > 6.0% and 18kg/m^2 and 300 mg/g for 2 consecutive times), and other possible causes of increased urinary protein have been excluded; 7. Those who are willing and able to carry out treatment and follow-up according to the requirements of the plan, and can carry out basic treatment according to the doctor's advice.
Exclusion criteria
Exclusion criteria: 1. Known allergies or have been allergic to blood products and drugs used in this study; 2. Patients with ketoacidosis within 1 month before screening; 3. There are serious complications of diabetes at the time of screening: such as severe proliferative diabetic retinopathy, history of kidney transplantation, active peripheral vascular disease; 4. Uncontrolled hypertension (defined as systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 100 mmHg); 5. Patients with acute myocardial infarction, or uncontrolled angina pectoris, uncontrolled arrhythmia, severe heart failure and other heart diseases within 6 months before screening; new cerebrovascular accident within 6 months before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine protein/creatinine( ACR );Kidney function (eGFR); | — |
Secondary
| Measure | Time frame |
|---|---|
| C-piptide levels;glucose levels at fasting/postprandial;Glycosylated hemoglobin levels;Safety at week 12 and 24 after umbilical cord blood intravenous infusion;Transforming growth factor beta, insulin-like growth factor 1, hepatocyte growth factor levels; | — |
Countries
China
Contacts
Public ContactZhu Lei
Shandong Provincial Third Hospital
Outcome results
None listed