Extracorporeal Photopheresis (ECP) After Lung Transplantation

Lung Transplant Rejection Clinical Trial

Official title:

Prophylactic Use of Extracorporeal Photopheresis (ECP) After Lung Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05721079
• Other study ID #: ECP-LUTX V 3.0
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Transplant Infection
• Lung Transplant Rejection

Intervention

Device:
• ECP (Extracorporeal Photopheresis System)
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.

Locations

Country	Name	City	State
Austria	Medical University Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acute cellular rejection	patients with acute rejection, biopsy proven with ISHLT grade > 1 histology	12 months