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

Launched by THE NORDIC NETWORK FOR CLINICAL ISLET TRANSPLANTATION · Oct 17, 2013

Keywords

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Gender

ALL

Eligibility criteria

• 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.