Infusion of Autologous T Regulatory Cells (T Reg) at the Time of Transplantation of Allogenic Islets of Langerhans
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type1diabetes
- Sponsor
- The Nordic Network For Clinical Islet Transplantation
- Enrollment
- 8
- Locations
- 2
- Primary Endpoint
- Infections
- Last Updated
- 5 years ago
Overview
Brief Summary
Open single armed study to investigate safety and feasibility of administrating autologous T regulatory cells at the time of allogenic islet transplantation.
Detailed Description
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient must be registered on the waiting list within The Nordic Network for Clinical Islet Transplantation
- •Type 1 diabetes with diagnosed \<40years of age and with\>5 years of exogenous insulin use
- •C peptide \< 0.1 nmol/L at MMTT if no previous islet transplant
- •Adequate previous treatment by an experienced diabetologist
- •Patient must understand and be able to sign an informed consent
Exclusion Criteria
- •Patient with a previous transplant other than islets
- •Patient with an BMI\>30
- •Patient with an need of more than 1U/kg of insulin per 24h
- •Repeated abnormal liver function tests
- •non stable retinopathy
- •known abnormalities in coagulation
- •known malignancies
- •non stable heart conditions
- •active infections
- •serological proof of hepatitis B or C or HIV
Outcomes
Primary Outcomes
Infections
Time Frame: 0-90 days post transplantation
Number of treatment requiering infections in each patient during follow up
Thrombosis
Time Frame: 0-75 days post transplant
Number of patients with thrombosis in portal veins shown by ultrasound post operative day 1 or later
Immunization
Time Frame: 90 days post transplantation
Number of patients with new anti HLA antibodies found at 90 days post transplantation compared to baseline
Bleeding
Time Frame: 0-1 days post transplant
Number of patients with \>20g/L reduction of haemoglobine and signs of bleeding shown by ultrasound post operative day 1
Liver function
Time Frame: 0-75days
Number of patients with an elevation of transaminases \> 5 times upper normal level during follow up
Islet graft failure
Time Frame: day 75
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.
Secondary Outcomes
- Hypoglycemic unawareness(day 75)
- PRA level(day 90)
- HbA1c(day 75)
- HbA1c and hypoglycemic unawareness combined(day 75)
- Insulin independence(day 75)
- Islet function(day 75)