Bet Cell Therapy in Diabetes Type 1

Inclusion Criteria

• •Group A:
• •Patients with loss of long-term function after intraportal implantation (- Patients with type 1 insulin-dependent diabetes who received two intraportal implantations \> 12 months ago.
• •Random C-peptide between 0.09 and 0.5 ng/dl (glycemia between 100 and 200 mg/dl)
• •Cooperative and reliable patient giving informed consent by signature
• •Group B:
• •Patients that are candidates for islet cell transplantation - age 18-65 years, male or female, Caucasian or not; only subjects \< 50 yrs will be allocated to the rituximab treatment arm
• •body weight \< 100 kg; patients with a bodyweight of \< 80kg, will receive priority
• •patients with a BMI ≤ 27 kg/m2 will receive priority
• •Type 1 insulin-dependent diabetes
• •C-peptide \< 0.07 nmol/l (\< 0.2 µg/l) 6 min. after glucagon IV (1mg) (glycemia \> 180 mg/dl)
• •Intensive insulin therapy for more than two years, patients with insulin pump during at least 2 months before inclusion will receive priority
• •Patients should have at least one of the following chronic complications of diabetes:
• •* albuminuria 30-1000mg/ 24hrs on 3 separate determinations (\>1 month) outside an episode of illness, despite intake of ACE inhibitors; mean systolic blood pressure should be under 130 mmHg and mean diastolic blood pressure under 85 mmHg, when measured at home with ambulatory BP monitoring
• •* moderate or severe non-proliferative or proliferative retinopathy
• •* hypoglycemic unawareness
• •Cooperative and reliable patient giving informed consent by signature