Extracorporeal Photopheresis in Liver Transplantation. Phase II Clinical Trial in Safety and Efficacy in Patients With Gradual Decrease of Immunosuppression. (FEC-TH)

The Cellular Therapy Network (TerCel)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Liver Transplantation

Immunosuppression

Treatments

Procedure: Extracorporeal Photopheresis Procedure (FEC)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01824368

2012-000633-39 (EudraCT Number)

FEC-TH

Details and patient eligibility

About

The purpose of this study is to evaluate the safety of extracorporeal photopheresis in patients with long-standing liver transplantation subjected to a progressive reduction of immunosuppression by complications arising from its use.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have been receiving liver transplant two years ago.
Be 18 years or older.
Treatment with immunosuppression including cyclosporine or tacrolimus.
Having a normal liver function in the last year
Not have suffered acute rejection in the last year and have no chronic rejection
Submit any significant side effects from medication immunosuppressive (hypertension, creatinine greater than 1.7 mgDl, diabetes, morbid obesity, osteoporosis, hyperlipidemia, severe hirsutism, neurotoxicity novo malignancy, etc.)
Etiology of underlying disease: alcoholic cirrhosis with or without hepatocarcinoma, metabolic diseases, amyloidotic polyneuropathy family, biliary atresia, fulminant hepatitis non-A, non-B, non-C, cirrhosis cryptogenic and generally causes no viral or autoimmune.
Patients offering sufficient guarantees of adherence to protocol
Patients who give written informed consent for participate in the study.
It is necessary that the patient meets all inclusion criteria.

Exclusion criteria

Underlying disease of the autoimmune (primary sclerosing cholangitis, autoimmune cirrhosis, primary biliary cirrhosis) or epatocarcinoma about cirrhosis of viral or autoimmune.
Patients with chronic rejection, or acute rejection in the last year.
Patients with liver retransplantation.
patients with history of hypersensitivity or idiosyncratic reactions to methoxsalen, psoralen the compounds or any of the excipients.
patients with melanoma, cutaneous basal cell carcinoma or squamous cell coexistent.
Patients with aphakia.
Patients taking Oxoralen.
Pregnant women or nursing mothers, or adults of childbearing age not using effective contraception.
Participation in another clinical trial.
Inability to understand informed consent.