Status:
UNKNOWN
Long-term Function of Beta Cell Allografts in Non-uremic Type 1 Diabetic Patients
Lead Sponsor:
AZ-VUB
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The present proof of concept study addresses the following specific aims: The general objectives of this work are: 1. To increase and maintain the functional beta-cell mass after islet transplantati...
Detailed Description
1. Aim 1: To increase functional beta cell mass by adding rituximab at first implantation 2. Aim 2: To increase functional beta cell mass by adding basilixumab at second implantation 3. Aim 3: To asse...
Eligibility Criteria
Inclusion
- 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 mg/dl)
- 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 diabetes:
- 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 monitoring
- Moderate or severe non-proliferative or proliferative retinopathy
- Hypoglycemic unawareness
- Cooperative and reliable patient giving informed consent by signature
Exclusion
- 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
- Hemoglobinopathy
- 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 potential
- 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 study, 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00798785
Start Date
October 1 2006
End Date
December 1 2014
Last Update
December 30 2013
Active Locations (4)
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1
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium
2
University Hospital Brussels
Brussels, Belgium, 1090
3
Hopital Erasme
Brussels, Belgium
4
University Hospital Leuven
Leuven, Belgium, 3000