Islet transplantation using brain-dead donors and donors after cardiac death for patients with insulin-dependent diabetes mellitus suffering from complicating hypoglycemia unawareness
- Conditions
- Type 1 diabetes
- Registration Number
- JPRN-UMIN000003977
- Lead Sponsor
- The Japanese Pancreas and Islet Transplantation Association
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 9
Not provided
1.BMI > 27 kg/m2 or weight > 80 kg. 2.Insulin requirement of > 0.8 IU/kg/day or 55 U/day. 3.Mean HbA1c value of several measurements in the previous 12 months > 10%. 4.Untreated proliferative diabetic retinopathy. 5.Blood pressure: SBP > 160 mmHg or DBP > 100 mmHg. 6.Creatinine clearance < 60 mL/min (applied only to islet transplantation alone case) 7.Presence of proteinuria > 1 g/day. 8.For female participants: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 3 months after discontinuation. For male participants: Intent to procreate during the duration of the study or within 3 months after discontinuation or unwillingness to use effective measures of contraception. Oral contraceptives, Norplant, Depo-Provera, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable. 9.Active infection including hepatitis B, hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB. Positive tests are acceptable only if associated with a history of previous vaccination in the absence of any sign of active infection. Positive tests are otherwise not acceptable, even in the absence of any active infection at the time of evaluation. 10.Negative screen for Epstein-Barr Virus (EBV) by IgG determination. 11.Difficulty of administration for laboratory and physical tests for evaluation or regular outpatient visits. 12.Mental abnormalities to hinder medical procedure under protocol (Assessment by psychiatrists is required and final decision is made by investigators in charge) 13.Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of subjects with HbA1c<7.0% and who are free of severe hypoglycemic events (from day 90 to day 365) one years after the first islet cell infusion.
- Secondary Outcome Measures
Name Time Method