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

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ClinicalTrials.gov Identifier: NCT01548729
Recruitment Status : Unknown
Verified March 2016 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : March 8, 2012
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2012
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. - C peptide stimulated by glucagon [ Time Frame: Success if Δ C peptide > 2 , 12 months after transplant ]

Secondary Outcome Measures :
  1. - Ratio [ C-peptide T6min/ C-peptide T0] : [ Time Frame: Every 6 months during 1 year after transplant ]
  2. - HbA1c : [ Time Frame: Every 3 months during 1 year after transplant ]
  3. - Needs in insulin ( UI / j ) : [ Time Frame: Every 3 months during 1 year after transplant ]
  4. - Number of hypoglycemia minor : [ Time Frame: Every 6 months during 1 year after transplant ]
  5. - Number of hypoglycemia major : [ Time Frame: 1 year after transplant ]
  6. - VEMS (Maximal Expired Volume per second) : [ Time Frame: Every 1 month during 1 year after transplant ]
  7. - CVF ( Forced Vital Capacity) : [ Time Frame: Every 1 month during 1 year after transplant ]
  8. - index Tiffeneau : [ Time Frame: Every 1 month during 1 year after transplant ]
  9. Number of episodes of infection lung : [ Time Frame: Every 1 month during 1 year after transplant ]
  10. - Test of walking : [ Time Frame: Every 3 months during 1 year after transplant ]
  11. Measure of the quality of life from questionnaires filled by the patient : [ Time Frame: Every 6 months during 1 year after transplant ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548729


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

Locations
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Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Laurence KESSLER, MD, PhD Hôpitaux Universitaires de Strasbourg
Principal Investigator: Pierre Yves BENHAMOU, MD, phD University Hospital, Grenoble
Principal Investigator: Dominique Grenet, MD HOPITAL FOCH DE SURESNES
Principal Investigator: Charles THIVOLET, MD Hospices Civils de Lyon
Principal Investigator: Thierry BERNEY, MD PhD CENTRE ROMAND DE TRANSPLANTATION - SUISSE
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01548729    
Other Study ID Numbers: 4790
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016
Keywords provided by University Hospital, Strasbourg, France:
Cystic Fibrosis
Diabetes Related Cystic Fibrosis
Lung transplantation
Pancreatic islets
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases