Open single armed study to investigate safety and feasibility of administrating autologous T regulatory cells at the time of allogenic islet transplantation.
Open single armed study to investigate safety and feasibility of administrating autologous T regulatory cells at the time of allogenic islet transplantation. Patients are recruited from the waiting list for islet transplantation within The Nordic Network for Clinical Islet Transplantation. Patients included in the study will undergo apheresis while on the waiting list. T regulatory cells will be sorted out and frozen. Autologous, non modified T regs will then be infused simultaneously intraportally with the islet graft at transplantation. Patients will be followed for safety and efficacy regarding the islet transplantation over three months
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Enriched autologous T regulatory cells are given back to the patient at the time of islet transplantation
Karolinska University Hospital
Stockholm, Sweden
Uppsala University Hospital
Uppsala, Sweden
Bleeding
Number of patients with \>20g/L reduction of haemoglobine and signs of bleeding shown by ultrasound post operative day 1
Time frame: 0-1 days post transplant
Thrombosis
Number of patients with thrombosis in portal veins shown by ultrasound post operative day 1 or later
Time frame: 0-75 days post transplant
Liver function
Number of patients with an elevation of transaminases \> 5 times upper normal level during follow up
Time frame: 0-75days
Infections
Number of treatment requiering infections in each patient during follow up
Time frame: 0-90 days post transplantation
Islet graft failure
Number of patients with islet graft failure shown as C peptide \<0.1 nmol/L fasting or \<0.3 nmol/L (90min) at a MMTT day 75 or lack of improvement compared to baseline if transplanted before.
Time frame: day 75
Immunization
Number of patients with new anti HLA antibodies found at 90 days post transplantation compared to baseline
Time frame: 90 days post transplantation
Islet function
Fraction of patients with a C-peptide level above 0.1 nmol/L fasting or 0.3 nmol/L (90min) at a MMTT day 75
Time frame: day 75
Insulin independence
Fraction of patients without need of exogeous insulin (ADA criteria) at day 75 post transplantation
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Time frame: day 75
HbA1c
Mean reduction of HbA1c at day 75 compared to baseline(%)
Time frame: day 75
Hypoglycemic unawareness
Number of patients with a reduced Clarke hypoglycemia awareness score day 75 (+/-5) post transplantation compared to baseline
Time frame: day 75
HbA1c and hypoglycemic unawareness combined
Number of patients with both a HbA1c ≤ 6.5% (DCCT) and lack of severe hypoglycemia at day 75 post transplantation
Time frame: day 75
PRA level
Number of patients with a rise in PRA (panel reactive antibodies) with more than 10% at 90 days post transplantation
Time frame: day 90