Extracorporeal Photopheresis (ECP) After Lung Transplantation

Study Overview
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Brief Summary
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The purpose of this study is to investigate the use of ECP for lung-transplanted patients to reduce the occurrence of acute and chronic rejection and CMV-infection.

Detailed Description
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The intention of the planned study is the use of ECP as a form of induction treatment in combination with standard immunosuppressive therapy (IST). Two randomized cohorts (each group 31 patients), all pats with COPD, will be investigated - group A ECP with standard triple IST vs group B just with IST. Endpoints are the incidence of acute rejection episodes (about 30-40% incidence within the first year) and the development of early chronic allograft dysfunction (CLAD). Further parameters to be investigated are the number of CMV-infectious complications. Parallel to the clinical parameters and investigation of immunologic test will be performed to get a better insight into the mechanisms of ECP on the immune system. The dynamics of Tregs and dentritic cell will be analysed to compare the influence of ECP vs standard IST on these parameters. How ECP is working is still a pending question but it seems to modulate the immune response maybe via influencing Tregs and apoptosis of upregulated T lymphocytes.

Official Title
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Prophylactic Use of Extracorporeal Photopheresis (ECP) After Lung Transplantation

Conditions
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Lung Transplant Infection, Lung Transplant Rejection

Intervention / Treatment
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* Device: ECP (Extracorporeal Photopheresis System)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing first lung transplantation Patient underlying disease COPD Male or female be 18 years or older Patients (male and female) must agree to use an acceptable method of birth control the treatment period of 3 months and 3 months afterward Patients must have a body weight more than 40 kg Patients must have a platelet count more than 20.000/cmm Patients must be willing and capable of understanding the purpose and risks of the study and must sign a statement of informed consent Exclusion Criteria: Previous organ transplantation Women who are pregnant and/or lactating Patients with hypersensitivity or allergy to both heparin and citrate products Patients who are unable to tolerate extracorporeal volume shifts associated with ECP treatment due to the presence of any of the following conditions: uncompensated congestive heart failure, pulmonary edema, renal failure or hepatic failure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ECP with standard triple IST<br> | Device: ECP (Extracorporeal Photopheresis System)<br>* After the cells have been inoculated with UVADE, the buffy coat/plasma suspension is irradiated with ultraviolet-A light and the infused back into the patient.<br>* Other names: 8-Methoxypsoralen extracopraeal;|
| Active Comparator: standard triple IST<br> | Device: ECP (Extracorporeal Photopheresis System)<br>* After the cells have been inoculated with UVADE, the buffy coat/plasma suspension is irradiated with ultraviolet-A light and the infused back into the patient.<br>* Other names: 8-Methoxypsoralen extracopraeal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute cellular rejection | patients with acute rejection, biopsy proven with ISHLT grade > 1 histology | 12 months |