post-transplant diabetes mellitus
Conditions
Interventions
experimental group:islets transplantation combined with mesenchymal stem cell
Sponsors
Tianjin First Center Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male and female diabetic patients age 18 to 65 years of age. 2. Mentally stable and able to comply with the procedures of the study protocol. 3. Ability to provide written informed consent. 4. At least 3 months after the transplantation of solid organs such as liver and kidney, patients should take immunosuppressive drugs regularly and take hormones of no more than 10mg/ day. 5. After organ transplantation, the graft function of the patient was stable and there was no rejection or serious infection for 3 consecutive months. 6. insulin-dependence, blood glucose levels are hard to control. 7. At least one time of severe hypoglycemia in the 12 months prior to study enrollment. 8. Involvement in intensive diabetes management defined as self monitoring of glucose values no less than a mean of three times each day.
Exclusion criteria
Exclusion criteria: 1. Body mass index (BMI) >30 kg/m2. 2. Failure of previous organ transplantation (except failure of pancreas-kidney transplantation due to thrombosis or surgical anastomosis). 3. Untreated proliferative diabetic retinopathy. 4. HbA1c > 10%. 5. Blood Pressure: SBP >160 mmHg or DBP >100 mmHg. 6. Panel reactive antibodies (PRA) > 50%, or PRA 300mg/g creatinine). 9. For female subjects: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation. 10. For male subjects: intent to procreate during the duration of the study or within 4 months after discontinuation or unwillingness to use effective measures of contraception. 11. Presence or history of active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB). Subjects with laboratory evidence of active infection are excluded even in the absence of clinical evidence of active infection. 12. Negative screen for Epstein-Barr Virus (EBV). 13. Invasive aspergillus, histoplasmosis, or coccidioidomycosis infection within one year prior to study enrollment. 14. Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin. 15. Known active alcohol or substance abuse. 16. A history of Factor V deficiency. 17. Baseline Hb below the lower limits of normal at the local laboratory; lymphopenia ( 1.5 times normal upper limits will exclude a patient. 20. Acute or chronic pancreatitis. 21. Symptomatic peptic ulcer disease. 22. Severe unremitting diarrhea, vomiting or other gastrointestinal disorders potentially interfering with the ability to absorb oral medications. 23. Hyperlipidemia despite medical therapy (fasting low-density lipoprotein [LDL] cholesterol >130 mg/dL, treated or untreated; and/or fasting triglycerides >200 mg/dL). 24. Administration of live attenuated vaccine(s) within 2 months of enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c;blood glucose;The percent reduction in insulin requirements;C-peptide derived from the oral glucose tolerance test (OGTT); | — |
Countries
China
Contacts
Public ContactWang Shusen
Tianjin First Center Hospital
Outcome results
None listed