Open-label Investigation of the Safety and Efficacy of DIABECELL in Patients With Type 1 Diabetes Mellitus

Exclusion Criteria

• •Type 2 diabetes, defined as age of onset \>30 years and/or a history of treatment with oral hypoglycaemic medications and/or insulin resistance (defined as an insulin dose requirement ≥1.2 U/kg/day)
• •An HbA1C \>12% prior to receipt of the first xenotransplant Body mass index (BMI) ≥28 kg/m2
• •Active infection, with plasma C-reactive protein ≥10 mg/L at baseline
• •Previous receipt of an organ, skin graft, or other tissue transplant from a human or animal donor
• •Treatment with immunosuppressive medications for another medical condition
• •Previous history of peritoneal disease or abnormal findings at baseline laparoscopy
• •Previous abdominal surgery, excluding uncomplicated appendectomy, cholecystectomy or caesarean section
• •History of pelvic inflammatory disease or endometriosis
• •Inability to tolerate oral medications or a history of significant malabsorption
• •HIV antibody and/or risk factors for HIV infection
• •Positive hepatitis C antibody, positive hepatitis B surface antigen and hepatitis B core antibody
• •Kidney disease, defined as serum creatinine \>130 μmol/L in men and \>110 μmol/L in women and/or urinary albumin \>500 mg/L and/or haematuria and/or active urinary sediment or casts
• •Diabetes microvascular complications defined as untreated, potentially vision-threatening proliferative or pre-proliferative retinopathy or maculopathy; painful peripheral neuropathy; autonomic neuropathy manifesting as postural hypotension; gastroparesis or diabetic enteropathy
• •Serious comorbid conditions that are likely to affect participation in the study, including:
• •1. Previous coronary heart disease manifesting as non-ST elevation myocardial infarction (NSTEMI), Q-wave infarction or unstable angina; coronary artery bypass graft (CABG); or percutaneous angioplasty
• •2. Previous cerebrovascular disease manifesting as transient ischaemic attacks (TIAs) or stroke
• •3. Peripheral vascular disease with previous amputation
• •4. History of New York Heart Association (NYHA) class II, III or IV congestive heart failure (CHF) and/or chronic atrial fibrillation
• •5. Chronic obstructive pulmonary disease (COPD) or asthma with previous hospitalisation for decompensation; a requirement for mechanical ventilation at any stage; or long-term treatment with oral corticosteroids
• •6. Liver disease with abnormal liver function tests defined as serum bilirubin ≥20 µmol/L, and/or ALT ≥100 U/L, and/or GGT ≥100 U/L, and/or albumin \<35 g/L
• •7. Haematological disorders, including haemoglobin ≤110 g/L or platelet count \<80 x 109/L
• •8. Peptic ulcer disease and/or history of previous gastrointestinal bleeding
• •9. Malignancy other than basal cell carcinoma
• •10. History of epilepsy
• •11. Untreated hypothyroidism
• •12. Known adrenal insufficiency
• •History of drug, substance or alcohol addiction
• •Any factor detected from psychometric evaluation at Visit 2 pre-transplant during the screening period which may in the opinion of the Clinical Psychologist affect an individual's ability to fully participate in the study
• •Any other condition that, in the opinion of the Investigator, may interfere with adherence to the study protocol, including dementia, mental illness, or a history of non-adherence to appointments or treatments