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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2012 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01548729
First received: February 10, 2012
Last updated: March 5, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
Diabetes Related Cystic Fibrosis
Procedure: Combined pancreatic islet and lung transplantation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Metabolic Efficiency of Combined Pancreatic Islet and Lung Transplant for the Treatment of End-Stage Cystic Fibrosis : a Pilot Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • - C peptide stimulated by glucagon [ Time Frame: Success if Δ C peptide > 2 , 12 months after transplant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - Ratio [ C-peptide T6min/ C-peptide T0] : [ Time Frame: Every 6 months during 1 year after transplant ] [ Designated as safety issue: No ]
  • - HbA1c : [ Time Frame: Every 3 months during 1 year after transplant ] [ Designated as safety issue: No ]
  • - Needs in insulin ( UI / j ) : [ Time Frame: Every 3 months during 1 year after transplant ] [ Designated as safety issue: No ]
  • - Number of hypoglycemia minor : [ Time Frame: Every 6 months during 1 year after transplant ] [ Designated as safety issue: No ]
  • - Number of hypoglycemia major : [ Time Frame: 1 year after transplant ] [ Designated as safety issue: No ]
  • - VEMS (Maximal Expired Volume per second) : [ Time Frame: Every 1 month during 1 year after transplant ] [ Designated as safety issue: No ]
  • - CVF ( Forced Vital Capacity) : [ Time Frame: Every 1 month during 1 year after transplant ] [ Designated as safety issue: No ]
  • - index Tiffeneau : [ Time Frame: Every 1 month during 1 year after transplant ] [ Designated as safety issue: No ]
  • Number of episodes of infection lung : [ Time Frame: Every 1 month during 1 year after transplant ] [ Designated as safety issue: No ]
  • - Test of walking : [ Time Frame: Every 3 months during 1 year after transplant ] [ Designated as safety issue: No ]
  • Measure of the quality of life from questionnaires filled by the patient : [ Time Frame: Every 6 months during 1 year after transplant ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: March 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patient with cystic fibrosis
Patients with end-stage cystic fibrosis
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Age > 18
  • Patient with cystic fibrosis
  • Patient able to respect the protocol procedures
  • Patient with end-stage respiratory insufficiency indicating a lung transplant
  • Patient on insulin therapy
  • Clinical history of cystic fibrosis related diabetes with no residual insulin secretion (C-peptide < 0,5 ng/mL) or no response to IV glucagon stimulation:

[peak stimulated C-peptide (T6min)/basal plasma C-peptide(T0)] < 2

  • The absence of insulin secretion will be verified 2 times before inclusion
  • Cystic fibrosis related diabetes duration > 3 years
  • Patient whose glycaemic control obtained with insulin therapy is not satisfactory and could significantly alter quality of life (HbA1c > 7% and/or MAGE index > 1,25). This situation is assessed by a diabetologist.
  • Social Security membership or benefit from Social Welfare
  • Patient who received the results of the medical evaluation required

Exclusion criteria:

  • Cystic fibrosis related diabetes duration < 3 years
  • Patient with no contra-indication for undergo a lung transplant
  • Patient under oral antidiabetic drug
  • Criteria specifically related to the islet intraportal injection procedure:

haemostasis problem, abnormalities of complete blood count, documented liver pathology (alkaline phosphatases, gamma GT, transaminases levels over three times normal values); pancreatitis history, gallbladder stones that could potentially migrate; HLA hyperimmunisation (PRA > 20%).

  • Portal hypertension identified by oesophageal varice and/or hypersplenism (platelets < 120 000 /mm3) or Child-Pugh score > 6.
  • Exclusion criteria non-specifically related to islet infusion: evolutive vascular disease, evolutive cardiopathy (especially myocardial infarction less than 6 months ago, cerebrovascular stroke less than 6 months ago, evolutive arteritis with trophic disorders); systemic infection including hepatitis B or C and HIV ; leuconeutropenia (< 1 500/μL); thrombocytopenia (< 100 000/μL), non-stabilized neoplastic pathology; antecedent of breast cancer or melanoma; pregnancy or project of pregnancy within the next 24 months or current breast-feeding; poor therapeutic compliance
  • Alcoholic intoxication or drug addiction
  • Use of a medical treatment under investigation within one month before inclusion
  • Patient restricted of freedom or unable to give his consent
  • All medical situation assessed by an investigator which could interfere with the good management of the project
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01548729

Contacts
Contact: Laurence KESSLER, MD, PhD 03 88 11 62 67 laurence.kessler@chru-strasbourg.fr

Locations
France
Service de Radiologie Interventionnelle, CHU de Grenoble Not yet recruiting
Grenoble, France, 38043
Contact: Frédéric Thony, MD    04 76 76 89 09    fthony@chu-grenoble.fr   
Contact: Christophe Sengel, MD    04 76 76 89 09    csengel@chu-grenoble.fr   
CRCM AdulteCHU de Grenoble, Hôpital A. Michallon Not yet recruiting
Grenoble, France, 38 043
Contact: Sébastien QUETANT, MD    04 76 76 75 93    squetant@chu-grenoble.fr   
Nephrologie, CHU Grenoble Not yet recruiting
Grenoble, France, 38043
Contact: François Bayle, MD    04 76 76 54 60    FBayle@chu-grenoble.fr   
Réanimation Cardiovasculaire et Thoracique, Hôpital Michallon Not yet recruiting
Grenoble, France, 38043
Contact: Michel Durand, MD    04 76 76 55 10    MDurand@chu-grenoble.fr   
Service de Pneumologie, Hôpital A. MICHALLON , CHU de Grenoble Not yet recruiting
Grenoble, France, 38700
Contact: Christophe Pison, MD, PhD    04 76 76 58 98    CPison@chu-grenoble.fr   
Contact: Sébastien QUETANT, MD    04 76 76 75 93    squetant@chu-grenoble.fr   
Service de Chirurgie Cardiaque, CHU Grenoble Not yet recruiting
Grenoble, France, 38043
Contact: Olivier Chavanon, MD, PhD    04 76 76 54 62    ochavanon@chu-grenoble.fr   
Service d'Endocrinologie, CHU de Grenoble Not yet recruiting
Grenoble, France, 38043
Contact: Pierre.Yves Benhamou, MD, PhD    04 76 76 88 56    PYBenhamou@chu-grenoble.fr   
Service d'Urologie et chirurgie de la Transplantation, Groupement Hospitalier Edouard Herriot Not yet recruiting
Lyon, France, 69 437
Contact: Lionel Badet, MD, PhD    04 72 11 05 87    lionel.badet@chu-lyon.fr   
Service d'Endocrinologie, Pavillon médical Not yet recruiting
Lyon, France, 69495
Contact: Charles Thivolet, MD, PhD    04 78 86 14 87    charles.thivolet@chu-lyon.fr   
Service d'imagerie radiologique et de médecine nucléaire, Centre Hospitalier Lyon-Sud Not yet recruiting
Lyon, France, 69495
Contact: Pierre-Jean Valette, MD, PhD    04 78 86 21 37    pierre-jean.valette@chu-lyon.fr   
Contact: Capucine Mucol, MD    04 72 11 75 43    capucine.micol@chu-lyon.fr   
Service de médecine de la transplantation et immunologie clinique, Hôpital Edouard Herriot Not yet recruiting
Lyon, France, 69437
Contact: Emmanuel Morelon, MD, PhD    04 72 11 01 51    emmanuel.morelon@chu-lyon.fr   
CRCM adulte, Centre Hospitalier Lyon-Sud Not yet recruiting
Lyon, France, 69495
Contact: Isabelle Durieu, MD, PhD    04 78 86 13 52    isabelle.durieu@chu-lyon.fr   
Service de Chirurgie Thoracique, HOPITAL LOUIS PRADEL Not yet recruiting
Lyon, France, 69677
Contact: Olivier BASTIEN, MD, PhD    04 72 11 89 44    olivier.bastien@chu-lyon.fr   
Service de pneumologie, Hôpital Louis Pradel Not yet recruiting
Lyon, France, 69677
Contact: François Philit, MD, PhD    04 72 35 58 36    francois.philit@chu-lyon.fr   
Service de Chirurgie Thoracique, HOPITAL LOUIS PRADEL Not yet recruiting
Lyon, France, 69677
Contact: François TRONC, MD, PhD    04 72 35 74 64    francois.tronc@chu-lyon.fr   
Service de chirurgie, Nouvel Hôpital Civil Not yet recruiting
Strasbourg, France, 67091
Contact: Gilbert Massard, MD, PhD    03 69 55 07 98    Gilbert.Massard@chru-strasbourg.fr   
Service d'Anesthésie-Réanimations Chirurgicales Not yet recruiting
Strasbourg, France, 67091
Contact: Annick Steib, MD, PhD    03.69.55.04.45    annick.steib@chru-strasbourg.fr   
Service de Radiologie, Hôpital de Hautepierre Not yet recruiting
Strasbourg, France, 67098
Contact: Michel Greget, MD, PhD    03 88 12 78 72    michel.greget@chru-strasbourg.fr   
Service de pneumologie, Nouvel Hôpital Civil Not yet recruiting
Strasbourg, France, 67091
Contact: Romain Kessler, MD, PhD    03 69 55 06 46    romain.kessler@chru-strasbourg.fr   
Service d'Anesthésie-Réanimations chirurgicales, Nouvel Hôpital Civil Not yet recruiting
Strasbourg, France, 67091
Contact: Philippe Wolf, Md, PhD    03 88 12 72 78    philippe.wolf@chru-strasbourg.fr   
Service d'endocrinologie, diabète et maladies métaboliques Not yet recruiting
Strasbourg, France, 67 091
Contact: Laurence Kessler, MD, PhD    03 88 11 62 67    laurence.kessler@chru-strasbourg.fr   
Principal Investigator: Laurence Kessler, MD, PhD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Laurence KESSLER, MD, PhD Hôpitaux Universitaires de Strasbourg
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01548729     History of Changes
Other Study ID Numbers: 4790
Study First Received: February 10, 2012
Last Updated: March 5, 2012
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:
Cystic Fibrosis
Diabetes Related Cystic Fibrosis
Lung transplantation
Pancreatic islets

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014