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

February 10, 2012
March 5, 2012
March 2012
March 2017   (final data collection date for primary outcome measure)
- C peptide stimulated by glucagon [ Time Frame: Success if Δ C peptide > 2 , 12 months after transplant ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01548729 on ClinicalTrials.gov Archive Site
  • - 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 ]
Same as current
Not Provided
Not Provided
 
Metabolic Efficiency of Combined Pancreatic Islet and Lung Transplant for the Treatment of End-Stage Cystic Fibrosis
Metabolic Efficiency of Combined Pancreatic Islet and Lung Transplant for the Treatment of End-Stage Cystic Fibrosis : a Pilot Study

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cystic Fibrosis
  • Diabetes Related 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
Experimental: Patient with cystic fibrosis
Patients with end-stage cystic fibrosis
Intervention: Procedure: Combined pancreatic islet and lung transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
15
March 2017
March 2017   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Laurence KESSLER, MD, PhD 03 88 11 62 67 laurence.kessler@chru-strasbourg.fr
France
 
NCT01548729
4790
Yes
University Hospital, Strasbourg, France
University Hospital, Strasbourg, France
Not Provided
Principal Investigator: Laurence KESSLER, MD, PhD Hôpitaux Universitaires de Strasbourg
University Hospital, Strasbourg, France
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP