diabetes
Conditions
Interventions
Drug administration group:The regenerated islets were transplanted by portal vein interventional injection
Sponsors
Children's Hospital, Zhejiang University School of Medicine, National Clinical Research
Eligibility
Sex/Gender
All
Age
14 Years to 18 Years
Inclusion criteria
Inclusion criteria: Comply with 1.2.3, and one of 4-6: (1) Age: 14-18 years; (2) Diabetes history greater than 1 year; (3) C-peptide less than 0.1, insulin dependent and total daily insulin dose greater than 30 units; (4) Exogenous insulin intensive treatment still poor blood sugar control (or blood sugar fluctuation, glycation >8%); (5) Frequent episodes of hypoglycemia accompanied by unconsciousness; (6) Patients with diabetic nephropathy who need to receive kidney transplantation
Exclusion criteria
Exclusion criteria: Meet any of the following: (1) including but not limited to tuberculosis, active hepatitis, human immunodeficiency (HIV) test positive history, treponema syphilis antibody (TP) positive (2) complicated with serious organic diseases of the heart, lung, brain and other vital organs (3) complicated with serious complications of diabetes: including but not limited to renal insufficiency, retinal hemorrhage, diabetic foot, etc (4) Liver function test of total bilirubin, ALT and AST=2×ULN (5) Malignant tumors were untreated or less than 1 year after cure (6) severe gastrointestinal dysfunction, gastrointestinal immune disease, and could not take immunosuppressants (7) Participants had participated in other clinical trials within 3 months before admission (8) Patients requiring long-term oral/intravenous glucocorticoids for a variety of medical conditions (9) The investigator determined that there was clear evidence of severe, active, uncontrolled endocrine or autoimmune abnormalities in the patient (10) other conditions that the investigator determined were not suitable for participation in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes in glycosylated hemoglobin from baseline to exit group;Changes in exogenous insulin use from baseline to exit group; | — |
Secondary
| Measure | Time frame |
|---|---|
| changes in fasting and postprandial C-peptide levels from baseline to exit;Changes in the incidence of hypoglycemia from baseline to exit group;Changes in fasting and postprandial endogenous insulin from baseline to exit group; | — |
Countries
China
Contacts
Public ContactJunfen Fu
Children's Hospital, Zhejiang University School of Medicine, National Clinical Research
Outcome results
None listed