Regulatory T Cells in Type 1 Diabetes Patients Treated With IL-2

Launched by CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST · Apr 5, 2013

Keywords

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • Written informed consent
• • Type 1 diabetes
• • 18-50 years
• • Duration of diabetes less than 24 months from diagnosis
• • One positive autoantibody (anti-islet cell, anti-GAD, anti-IA2, anti-ZnT8)
• Exclusion Criteria:
• • Hypersensitivity to aldesleukin or any of the excipients
• • History of severe cardiac disease
• • History of malignancy within the past 5 years (with the exception of localized carcinoma of the skin that had been resected for cure or cervical carcinoma in situ)
• • History or concurrent use of immunosuppressive agents or steroids
• • History of unstable diabetes with recurrent hypoglycaemia
• • Active autoimmune, hyper or hypothyroidism
• • Active clinical infection
• • Major pre-existing organ dysfunction or previous organ allograft
• • Females who are pregnant, lactating or intend to get pregnant during the study - Males who intend to father a pregnancy during the study
• • Donation of more than 500 ml of blood within 2 months prior to aldesleukin administration
• • Participation in a previous therapeutic clinical trial within 2 months prior to aldesleukin administration
• • Abnormal ECG Abnormal full blood count, chronic renal failure (Stage 3,4,5) and/or evidence impaired liver function
• • Positive Hepatitis B surface Antigen (HBsAg) or Hepatitis C serology or Human Immunodeficiency Virus (HIV) test
• • Any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the patient ineligible for inclusion because of a safety concern