Trials / Completed
CompletedNCT06899828
Unraveling Mechanism of Action of Extracorporeal Photopheresis in Heart and Lung Transplant Patients
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 26 (actual)
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective observational single center national study. Lung and heart transplant patients with a definite diagnosis of chronic lung allograft dysfunction (CLAD) or cardiac allograft vasculopathy (CAV) will be assigned for extracorporeal photopheresis (ECP) as per common clinical practice to a 6-month ECP cycle with the aim of limiting progression of organ dysfunction. The exact mechanisms of ECP in chronic rejection after lung and heart transplantation (CLAD and CAV) are elusive but it is thought to induce apoptosis of lymphocytes and to generate regulatory T cells, which modulate transplant immune rejection by a complex effect.
Detailed description
The primary objective of the present study is to identify the biomarkers associated to response to ECP after 6 months of treatment.
Conditions
- Heart Transplanted Patients
- Lung Transplanted Patients
- Chronic Lung Allograft Dysfunction (CLAD)
- Cardiac Allograft Vasculopathy
Timeline
- Start date
- 2023-04-17
- Primary completion
- 2024-07-31
- Completion
- 2024-07-31
- First posted
- 2025-03-28
- Last updated
- 2025-03-28
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT06899828. Inclusion in this directory is not an endorsement.