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

NCT ID: NCT04820270

Last Updated: 2021-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-20
• Study Completion Date: 2021-07-31

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

Conditions

Type1diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous Tregs in allogenic islet transplantation

Autologous Tregs are given simultaneously to the patient with the islets

Group Type: EXPERIMENTAL

Autologous T regulatory cells

Intervention Type: OTHER

Enriched autologous T regulatory cells are given back to the patient at the time of islet transplantation

Interventions

Autologous T regulatory cells

Enriched autologous T regulatory cells are given back to the patient at the time of islet transplantation

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Nordic Network For Clinical Islet Transplantation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Torbjörn Lundgren, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

Karolinska University Hospital

Stockholm, , Sweden

Uppsala University Hospital

Uppsala, , Sweden

Countries

Sweden

Other Identifiers

AutoTregIsl

Identifier Type: -

Identifier Source: org_study_id