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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05721079
Other study ID # ECP-LUTX V 3.0
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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