Last updated on December 2013

Long-term Function of Beta Cell Allografts in Non-uremic Type 1 Diabetic Patients

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Diabetes Mellitus | Type 1
  • Age: Between 18 - 65 Years
  • Gender: Male or Female
  • Other:
    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
    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
    Plasma creatinine <2 mg/dl and albuminuria 30-1000 mg/ 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
    Moderate or severe non-proliferative or proliferative retinopathy
    Hypoglycemic unawareness
    Cooperative and reliable patient giving informed consent by signature

You may not be eligible for this study if the following are true:

  • Smoker
    EBV antibody negativity
    HIV 1 & 2 antibody positivity
    CMV IgM positivity
    Plasma creatinine ≥ 2 mg/dl and/or albuminuria ≥1000 mg/24 hrs
    History of thrombosis or pulmonary embolism
    History of malignancy, tuberculosis or chronic viral hepatitis
    History of any other serious illness which could be relevant for the protocol
    Presence of HLA antibodies
    Blood donation within one month prior to screening or during the study
    Symptoms and/or signs of infection, particularly (present or past) endocarditis,
    osteomyelitis, past tuberculosis with requirement for therapy
    Any history of hepatic or neoplastic disease
    Any history of renal disease (except diabetes)
    Abnormal liver function tests and /or NMR of liver
    History of any illness that, in the opinion of the investigator, might confound the
    results of the study or pose additional risks to the patient
    Pregnancy or use of inadequate contraception by female patients of childbearing
    Use of illicit drugs or overconsumption of alcohol (> 3 beers/day) or history of drug
    or alcohol abuse
    Being legally incapacitated, having significant emotional problems at the time of the
    tudy, or having a history of psychiatric disorders
    Having received antidepressant medications during the last 6 months
    Having participated the last 12 months or participating in another clinical study

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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