Intraportal or Intramuscular Site for Islets in Simultaneous Islet and Kidney Transplantation

Inclusion Criteria:

• Male and female patients age 18 to 65 years of age.
• Ability to provide written informed consent.
• Mentally stable and able to comply with the procedures of the study protocol.
• Clinical history compatible with type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years at the time of enrolment.
• Absence of stimulated C-peptide <0.1 nmol/L in response to a MMTT.
• All subjects must have received adequate medical treatment of their diabetes under the guidance from an experienced diabetologist.
• All subjects must have renal failure and be eligible for renal transplantation according to local criteria.

Exclusion Criteria:

• Patients with prior organ transplants
• Patients that qualify for local simultaneous pancreas-kidney transplantation program and who prefer that option
• Patients with body mass index BMI > 28.
• Insulin requirement > 1 Unit/kg/day. If the patient is on peritoneal dialysis the same limit is set when the extra carbohydrates in the dialysis fluids have been accounted for.
• Consistently abnormal liver function tests ( > 1.5 x the upper limit of normal on two consecutive measurements > 2 weeks apart)
• Unstable diabetic retinopathy
• Hypercoagulability disorder or coagulopathy or International normalized ratio (INR)>1.5
• Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin
• Patients with unstable cardiovascular status
• Patients with active infections, unless treatment is not judged necessary by the investigators
• Patients with serological evidence of infection with HIV, hepatitis B (patients with serology consistent with previous vaccination and a history of vaccination are acceptable) or hepatitis C.