Clinical Enforcement of islet cell transplantation in our hospital
- Conditions
- Patients uncontrolled severe type 1 diabetes
- Registration Number
- JPRN-UMIN000019395
- Lead Sponsor
- agasaki University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Not provided
1.Body weight is greater than 80kg,or BMI is greater than 25kg/m2. 2.Insulin dose is over 0.8IU/kg/day day, or more than 55U/day. 3/The average value of HbA1C is more than 10.4% in the past year. 4.Patient has untreated proliferative diabetic retinopathy. 5.Systolic blood pressure is above 160mmHg or diastolic blood pressure is over 100mmHg. 6.eGFR is less than 60ml/min/1.73m2 (In case of islet transplantation alone). 7.Urine protein is more than 1g/day. 8.PRA(panel reactive antibody)is above 20%by flow cytometry. 9.Pregnancy test is positive or under the nursing. 10.Patient has following active infections. Hepatitis B or C, HIV, HTLV-I,or acid bacteriosis including tuberculosis. 11.Epstein-Barr IgG antibody is negative. 12.Patient has a history of invasive aspergillosis infection. 13.Patient has a history of cancer. However, completely resected squamous cell carcinoma or basal cell carcinoma of the skin is excluded. 14.Alchoholic or drug addict 15.Hemoglobin level is below normal limit; lymphopenia (<700/µL), neutropenia (<1,500/µL), or thrombocytopenia (platelets <100,000/µL). 16.Patient has a history of factor V deficiency. 17.Coagulation disorder or Anticoagulants are needed after transplantation. 18.Severe heart disease 1)Myocardial infarction in past past 6 months. 2)Ischemic heart failure that is diagnosed by cardiac function test in past one year. 3)Ejection fraction is less than 30%. 19.Liver function test values are sustained high AST,ALT(ALP, or total bilirubin values, continues more than 1.5 times the upper limit of normal) 20.Symptomatic cholelithiasis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of insulin independence The rate of graft survival
- Secondary Outcome Measures
Name Time Method