Type 1 Diabetes
Conditions
Interventions
Experimental group:Transplantation of islet-like cells derived from autologous chemical reprogramming induced pluripotent stem cell(CiPSC)
Sponsors
Tianjin First Center Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-60 years old (including 18 and 60 years old), male and female; 2. Type 1 diabetes patients (including those who have received organ transplantation such as liver and kidney); 3. Stimulated C-peptide<0.3ng/mL; 4. In recent 3 months, the glycosylated hemoglobin (HbA1c) was 7%-10%; 5. The patient had at least one severe hypoglycemia within 12 months before being included in the project; 6. Able to participate in strengthening blood glucose management and have good compliance; 7. Mentally stable and able to comply with the clinical research protocol; 8. Have full civil capacity for civil conduct and the ability to independently fill in written informed consent.
Exclusion criteria
Exclusion criteria: 1. Type 2 diabetes patients; 2. Body mass index (BMI)>30 kg/m2; 3. Untreated proliferative diabetes retinopathy; 4. Have a history of infectious diseases such as hepatitis B, hepatitis C, HIV and tuberculosis, or have active bacterial, fungal or viral infections (except mild local skin infections); 5. Serious heart disease, in accordance with any of the following: recent history of myocardial infarction (within 6 months), myocardial ischemia in the evaluation of cardiac muscle function in the past year, left ventricular ejection fraction 160 mmHg or diastolic blood pressure > 100 mmHg; 7. Liver function index: serum AST and ALT were 2 times higher than the upper limit of normal value; 8. Glomerular filtration rate (GFR) 1.5; 12. For female subjects: pregnancy test positive, lactation or unwilling to use effective contraceptive measures during the study period, male patients: intent to procreate or unwilling to use effective contraceptive measures during the study period; 13. Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin; 14. Have a history of tobacco, alcohol and drug abuse; 15. Serious gastrointestinal dysfunction, gastrointestinal immune disease, gastrointestinal ulcer, etc. , which may interfere with oral drug absorption; 16. Have serious psychological diseases; 17. Participated in other clinical trials in the past 3 months; 18. Participants deemed unsuitable for this clinical trial for other reasons; 19. Administration of live attenuated vaccine(s) within 2 months of enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c; | — |
Secondary
| Measure | Time frame |
|---|---|
| C-peptide;Insulin Requirement; | — |
Countries
China
Contacts
Public ContactShen Zhongyang
Tianjin First Center Hospital
Outcome results
None listed