Hepatic Insufficiency
Conditions
Keywords
Liver, transplantation, Immunosuppression, photopheresis, extracorporeal
Brief summary
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.
Detailed 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.
Interventions
PROCEDUREExtracorporeal photopheresis
Extracorporeal photopheresis with Methoxsalen(UVADEX)and immunosuppression reduction Extracorporeal photopheresis (ECP) is an immunomodulatory excellent technical tolerated initially designed for the treatment of cutaneous T-cell lymphoma and various autoimmune diseases, which has been proven effective in reversing episodes acute heart transplants, kidney and lung rejection, and in the treatment of Disease graft versus host both acute and chronic.
Sponsors
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serious Adverse Events associated with the procedure | 12 months |
| Non Serious Adverse Events | 12 months |
| Allograft Rejection | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hematological Parameters | 12 months | Basic hematological parameters: Hemoglobin, hematocrit, platelets and leukocytes. Metabolic parameters: Glucose, uric acid, triglycerides, cholesterol, HDL and LDL cholesterol. |
| Immunosuppressant level | 12 months | CyA, tacrolimus levels |
| Immunological evaluation | 12 months | Study of the evolution of subpopulations of blood mononuclear cells peripheral (T cells, B cells and dendritic cells) During removal of the SI measured by flow cytometry of different lymphocyte populations and are expressed as% and / or item # cells / L blood |
| Liver function test | 12 months | Total protein, albumin, bilirubin, GOT, GPT, alkaline phosphatase, gamma- GT, Quick index. |
| Renal Function test | 12 months | Creatinine, urea, glomerular filtration rate (MDRD), creatinine clearance |
Countries
Spain
Outcome results
None listed