Bet Cell Therapy in Diabetes Type 1
Type 1 Diabetes
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, Transplantation, Beta Cells, Encapsulation
Eligibility Criteria
Inclusion Criteria:
Group A:
Patients with loss of long-term function after intraportal implantation (- Patients with type 1 insulin-dependent diabetes who received two intraportal implantations > 12 months ago.
- Random C-peptide between 0.09 and 0.5 ng/dl (glycemia between 100 and 200 mg/dl)
- Cooperative and reliable patient giving informed consent by signature
Group B:
Patients that are candidates for islet cell transplantation - 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:
- albuminuria 30-1000mg/ 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:
Women of reproductive age
- Smoker
- EBV antibody negativity
- HIV 1 & 2 antibody positivity
- CMV IgM positivity
- Hepatitis B infection
- GFR < 45 ml/min/1.72 m2
- 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 clinical significant HLA antibodies
- Blood donation within one month prior to screening
- Symptoms and/or signs of infection, particularly (present or past) endocarditis, osteomyelitis
- 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
- Use of illicit drugs or overconsumption of alcohol (> 3 IU/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 a psychiatric disorder that may be exacerbated by the transplantation procedure or interfere with compliance during follow-up
- Having received antidepressant medications during the last 6 months
- Participating in another pharmacological study
Sites / Locations
- UZ BrusselRecruiting
- UZ LeuvenRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Group A
Group B
Patients with loss of long-term function after intraportal implantation
Patients that are candidates for islet cell transplantation