Long-term Function of Beta Cell Allografts in Non-uremic Type 1 Diabetic Patients (NCT00798785) | Clinical Trial Compass
UnknownPhase 1/2
Long-term Function of Beta Cell Allografts in Non-uremic Type 1 Diabetic Patients
Belgium50 participantsStarted 2006-10
Plain-language 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 transplantation under a condition of low-dose tacrolimus
2. To co-investigate the potential of alternative sites for encapsulated beta-cells
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 …
What they're measuring
1
Evidence of clinically relevant beta cell graft function