Infusion of Autologous T Regulatory Cells (T Reg) at the Time of Transplantation of Allogenic Islets of Langerhans

The Nordic Network For Clinical Islet Transplantation

Status: Unknown

Conditions: Type1diabetes

Treatments: Other: Autologous T regulatory cells

Study type: Interventional

Funder types: Other

Identifiers

NCT04820270

AutoTregIsl

Details and patient eligibility

About

Open single armed study to investigate safety and feasibility of administrating autologous T regulatory cells at the time of allogenic islet transplantation.

Full 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

Enrollment: 8 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Autologous Tregs in allogenic islet transplantation

Experimental group

Description:

Autologous Tregs are given simultaneously to the patient with the islets

Treatment:

Other: Autologous T regulatory cells