Metabolic Efficiency of Combined Pancreatic Islet and Lung Transplant for the Treatment of End-Stage Cystic Fibrosis

NCT01548729 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-03-30

No results posted yet for this study

Summary

Patients with end-stage cystic fibrosis (CF) and severe CF-related diabetes (CFRD) may benefit from combined lung-pancreatic islet transplantation. A recent case series showed that combined bilateral lung and pancreatic islet transplantation is a viable therapeutic option for patients with end-stage CF and CFRD. The use of different organs from a single donor may lead to reduced immunogenicity. As the prevalence of CFRD has increased dramatically with the improved life expectancy of patients with CF, islet transplantation should be considered at the end-stage CF. By restoring metabolic control, the investigators hypothesize that islet transplantation may improve the management of CF patients undergoing lung transplant and decrease the complication rate in the early postoperative period.

Conditions

  • Cystic Fibrosis
  • Diabetes Related Cystic Fibrosis
  • Insulin-dependent Diabetes

Interventions

PROCEDURE

Combined pancreatic islet and lung transplantation

Combined pancreatic islet and lung transplant from the same donor for the treatment of patients with end-stage cystic fibrosis

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Principal Investigators

  • Laurence KESSLER, MD, PhD · Hôpitaux Universitaires de Strasbourg

  • Pierre Yves BENHAMOU, MD, phD · University Hospital, Grenoble

  • Dominique Grenet, MD · HOPITAL FOCH DE SURESNES

  • Charles THIVOLET, MD · Hospices Civils de Lyon

  • Thierry BERNEY, MD PhD · CENTRE ROMAND DE TRANSPLANTATION - SUISSE

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-25
Primary Completion
2019-12-20
Completion
2019-12-20

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01548729 on ClinicalTrials.gov