NCT04820270

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: The Nordic Network For Clinical Islet Transplantation · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Autologous T regulatory cells	Enriched autologous T regulatory cells are given back to the patient at the time of islet transplantation

Timeline

• Start date: 2018-08-20
• Primary completion: 2021-04-30
• Completion: 2021-07-31
• First posted: 2021-03-29
• Last updated: 2021-03-29

Locations

2 sites across 1 country: Sweden