Clinical trial NCT04820270: Infusion of Autologous T Regulatory Cells (T Reg) at the Time of Transplantation of Allogenic Islets of Langerhans
Official title: Infusion of Autologous T Regulatory Cells (T Reg) at the Time of Transplantation of Allogenic Islets of Langerhans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type1diabetes
Keywords: Transplantation
Islets of Langerhans
T regulatory Cells (autologous)
Lead sponsor: The Nordic Network For Clinical Islet Transplantation
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm feasibility and safety study
Primary purpose: TREATMENT

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

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
* 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

Primary outcomes:
measure: Bleeding
timeFrame: 0-1 days post transplant
measure: Thrombosis
timeFrame: 0-75 days post transplant
measure: Liver function
timeFrame: 0-75days
measure: Infections
timeFrame: 0-90 days post transplantation
measure: Islet graft failure
timeFrame: day 75
measure: Immunization
timeFrame: 90 days post transplantation
Secondary outcomes:
measure: Islet function
timeFrame: day 75
measure: Insulin independence
timeFrame: day 75
measure: HbA1c
timeFrame: day 75
measure: Hypoglycemic unawareness
timeFrame: day 75
measure: HbA1c and hypoglycemic unawareness combined
timeFrame: day 75
measure: PRA level
timeFrame: day 90
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Torbjörn Lundgren, MD
role: PRINCIPAL_INVESTIGATOR
References: