Extracorporeal Photopheresis After Liver Transplant

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Status and phase

Completed

Phase 2

Conditions

Hepatic Insufficiency

Treatments

Procedure: Extracorporeal photopheresis

Study type

Interventional

Funder types

Other

Identifiers

NCT02090621

2012-000633-39 (EudraCT Number)

FEC-TH

Details and patient eligibility

About

The purpose of this study is to determine the safety of photopheresis for prophylaxis of allograft rejection in patients who are being withdrawal immunosuppression after liver transplantation.

Full description

The photopheresis (ECP) is a therapeutic approach based on the biological effect of ultraviolet light A on mononuclear cells collected by apheresis, and reinfused into the patient.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Liver transplantation 2 years ago
>18 years
Treatment with immunosuppression (Cyclosporine or tacrolimus)
Normal hepatic function during last year
No acute or chronic rejection
to have some secondary effect because of immunosuppressors
Previous disease: alcoholic liver cirrhosis with or without hepatocarcinoma, metabolic disease, amyloid polyneuropathy, hepatitis,cryptogenic cirrhosis and non autoimmune causes
Signing consent informed form

Exclusion criteria

Additional liver Transplantation
hypersensitivity to methoxsalen
Patients with melanoma ,cutaneous carcinoma
Patients with aphakia
Patients treated with oxsoralen
Pregnant women, lactating women or fertile adults that they don´t use a effective anticonception method
Involved in other assay.