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
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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