Clinical Study of Allogeneic Islet Transplantation for Treatment of type 1 diabetes
Not Applicable
Recruiting
- Conditions
- Type 1 Diabetes
- Registration Number
- JPRN-UMIN000014381
- Lead Sponsor
- ational Center for Global Health and Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 3
Inclusion Criteria
Not provided
Exclusion Criteria
Body mass index (BMI) >25 kg/m2 or patient weight >80kg. Insulin requirement of >0.8 IU/kg/day or >55 U/day. HbA1c >10%. Untreated proliferative diabetic retinopathy. Blood Pressure: SBP >160 mmHg or DBP >100 mmHg. eGFR <60 mL/min/1.73m^2 Presence or history of macroalbuminuria (>1g/day). Presence or history of panel-reactive anti-HLA antibodies above background by flow cytometry.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of subjects with an HbA1c <7.0% at Day 365 AND free of severe hypoglycemic events from Day 28 to Day 365 inclusive following the first islet transplant, with the day of transplant designated Day 0
- Secondary Outcome Measures
Name Time Method