Status:
UNKNOWN
Infusion of Autologous T Regulatory Cells (T Reg) at the Time of Transplantation of Allogenic Islets of Langerhans
Lead Sponsor:
The Nordic Network For Clinical Islet Transplantation
Conditions:
Type1diabetes
Eligibility:
All Genders
18-65 years
Phase:
NA
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 li...
Eligibility Criteria
Inclusion
- 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
- 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
- signs of portal hypertension
- patients that are pregnant, breast feeding or aim to become pregnant during the study period
- patients with a PRA \> 20%, positive cross match or known DSA
- patients with conditions that the investigator would consider unsafe to combine with islet transplantation
Key Trial Info
Start Date :
August 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04820270
Start Date
August 20 2018
End Date
July 31 2021
Last Update
March 29 2021
Active Locations (2)
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1
Karolinska University Hospital
Stockholm, Sweden, 14186
2
Uppsala University Hospital
Uppsala, Sweden