Type 2 Diabetes
Conditions
Interventions
1:Standard control group:Conventional therapy (SMT) plus whole body infusion of acellular suspension for 3 consecutive times with an interval of 1 week
2:Intravenous systemic infusion group: conventional therapy (SMT) + intravenous systemic infusion of hUCMSCs injection with cell dose of 1x10 ^ 6 / kg/ for 3 consecutive times with an interval of 1 we
3:Local infusion of dorsal pancreatic artery group: conventional therapy (SMT) + infusion of hUCMSCs injection into dorsal pancreatic artery, cell dose 1x10 ^ 6 / kg/, once.
4:Local infusion of dorsal pancreatic artery combined with intravenous systemic infusion group: routine treatment (SMT) + dorsal pancreatic artery infusion of hUCMSCs injection + intravenous systemic
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The diagnosis of T2DM (see Table 1, the WHO diagnostic criteria for diabetes in 1999); 2. Before routine treatment, 7% = HbA1c = 9.5%; before random grouping, it stabilized to 7% = HbA1c = 9.5%; 3. Age = 18 and < 70 years old; 4. Before grouping, the total insulin dosage was less than 100 IUBG/d; 5. Basic C-peptide = 0.3 ng/ml; 6. Understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Glutamate decarboxylase antibody (GADA) was positive.; 2.Within three months, thiazolidinedione (TZDs) was treated with thiazolidinedione; 3. Severe history of drug allergy or allergy; 4. Severe brain injury, resulting in severe neurological impairment; 5. Serious respiratory diseases; 6. More severe cardiovascular diseases, including blood pressure SBP = 180mmHg and / or DBP = 110mmHg or refractory hypertension; cardiac function grades III and IV (see Table 2, New York Heart Association (NYHA) classification); 7. Severe liver function abnormalities: liver function Child-Pugh score B, C (see Table 3, liver function Child-Pugh score scale); 8. More severe renal dysfunction: renal function CKD4, stage 5 (see Table 4, American Kidney Foundation CKD staging criteria); 9. With other serious or uncontrollable diabetic complications, such as stage V and VI of diabetic retinopathy; 10. Blood sugar continues to increase or seriously fluctuate, life-threatening; 11. Other serious endocrine diseases except diabetes; 12. Severe diseases of the blood system; 13. Serious or uncontrolled infections; 14. Known or suspected malignant tumor; positive for 15.HIV antibody; 16. More serious psychiatric diseases; 17. Women with pregnancy, planned pregnancy or possible pregnancy and lactation; 18. Drugs that affect glucose metabolism, such as glucocorticoids, thiazide diuretics, oral contraceptive, tricyclic antidepressants, etc., have been used or are being used within one month; 19.Alcohol and drug abusers; 20. Those who have participated in any other clinical trials within three months; 21. According to the researchers, any disease or condition that may endanger the safety of the subjects or compliance with the program.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose attainment rate (HbA1c) after stem cell therapy;The proportion of blood glucose reaching the standard and insulin reduction = 50% after stem cell treatment;Blood glucose control; | — |
Secondary
| Measure | Time frame |
|---|---|
| Islet ß-cell function;Insulin resistance function;Incidence of hypoglycemia;Blood glucose fluctuation;Related indexes of endocrine and metabolism;Diabetic complication index;Insulin / oral hypoglycemic drug reduction;Quality of life score; | — |
Countries
China
Contacts
Public Contactzhangfan
Peking University Shenzhen Hospital
Outcome results
None listed