Last updated on February 2018

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Diabetes Related Cystic Fibrosis | Cystic Fibrosis
  • Age: Between 18 - 60 Years
  • Gender: Male or Female

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/L); thrombocytopenia (< 100 000/L), 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

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.