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

NCT04820270 | Unknown

• 1 other identifier: AutoTregIsl
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Type1diabetes

Keywords

Transplantation; Islets of Langerhans; T regulatory Cells (autologous)

Outcome Measures

Primary Outcomes (6)

• Bleeding

  Number of patients with \>20g/L reduction of haemoglobine and signs of bleeding shown by ultrasound post operative day 1

  0-1 days post transplant

• Thrombosis

  Number of patients with thrombosis in portal veins shown by ultrasound post operative day 1 or later

  0-75 days post transplant

• Liver function

  Number of patients with an elevation of transaminases \> 5 times upper normal level during follow up

  0-75days

• Infections

  Number of treatment requiering infections in each patient during follow up

  0-90 days post transplantation

• Islet graft failure

  Number of patients with islet graft failure shown as C peptide \<0.1 nmol/L fasting or \<0.3 nmol/L (90min) at a MMTT day 75 or lack of improvement compared to baseline if transplanted before.

  day 75

• Immunization

  Number of patients with new anti HLA antibodies found at 90 days post transplantation compared to baseline

  90 days post transplantation

Secondary Outcomes (6)

• Islet function

  day 75

• Insulin independence

  day 75

• HbA1c

  day 75

• Hypoglycemic unawareness

  day 75

• HbA1c and hypoglycemic unawareness combined

  day 75

Study Arms (1)

Autologous Tregs in allogenic islet transplantation

EXPERIMENTAL

Autologous Tregs are given simultaneously to the patient with the islets

Other: Autologous T regulatory cells

Interventions

Autologous T regulatory cells OTHER

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

Autologous Tregs in allogenic islet transplantation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Nordic Network For Clinical Islet Transplantation: lead

Study Sites (2)

Karolinska University Hospital

Stockholm, 14186, Sweden

Location

Uppsala University Hospital

Uppsala, Sweden

Location

Study Officials

• Torbjörn Lundgren, MD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm feasibility and safety study

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 29, 2021
• Study Start: August 20, 2018
• Primary Completion: April 30, 2021
• Study Completion: July 31, 2021
• Last Updated: March 29, 2021

Record last verified: 2021-03

Locations

SE (2)