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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous Tregs in allogenic islet transplantation | Experimental | Autologous Tregs are given simultaneously to the patient with the islets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous T regulatory cells | Other | Enriched autologous T regulatory cells are given back to the patient at the time of islet transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding | Number of patients with >20g/L reduction of haemoglobine and signs of bleeding shown by ultrasound post operative day 1 | 0-1 days post transplant |
| Thrombosis | Number of patients with thrombosis in portal veins shown by ultrasound post operative day 1 or later | 0-75 days post transplant |
| Liver function | Number of patients with an elevation of transaminases > 5 times upper normal level during follow up | 0-75days |
| Infections | Number of treatment requiering infections in each patient during follow up | 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. | day 75 |
| Immunization | Number of patients with new anti HLA antibodies found at 90 days post transplantation compared to baseline | 90 days post transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | day 75 |
| Insulin independence | Fraction of patients without need of exogeous insulin (ADA criteria) at day 75 post transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Torbjörn Lundgren, MD | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | 14186 | Sweden | |||
| Uppsala University Hospital |
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Single arm feasibility and safety study
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| day 75 |
| HbA1c | Mean reduction of HbA1c at day 75 compared to baseline(%) | day 75 |
| Hypoglycemic unawareness | Number of patients with a reduced Clarke hypoglycemia awareness score day 75 (+/-5) post transplantation compared to baseline | 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 | day 75 |
| PRA level | Number of patients with a rise in PRA (panel reactive antibodies) with more than 10% at 90 days post transplantation | day 90 |
| Uppsala |
| Sweden |