Extracorporeal Photopheresis in Liver Transplantation. Phase II Clinical Trial in Safety and Efficacy in Patients With Gradual Decrease of Immunosuppression.

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2016

Conditions
Liver TransplantationImmunosuppression
Interventions
PROCEDURE

Extracorporeal Photopheresis Procedure (FEC)

"The FEC will be held in the Cellex (Therakos), and authorized device in routine use in our unit for performing FEC in the treatment of graft-versus-host and cutaneous T-cell lymphoma. After performing a blood count, will connect the patient to Cellex through a central or peripheral.~1500 mL typically be processed peripheral blood mononuclear fraction obtained by apheresis process. Then be added Uvadex (8-metoxipsolareno, 0.017 mL / mL) to the mononuclear fraction bag and proceed to photoactivation with UVA radiation.~Finally the photoactivated product is again infuse the patient. It will monitor the final blood count to assess hemoglobin and platelets. The entire procedure is performed in a single step and closed mode, with Cellex."

Trial Locations (1)

30120

University Hospital Virgen de la Arrixaca, El Palmar

All Listed Sponsors
collaborator

Spanish National Health System

OTHER

collaborator

Universidad de Murcia

OTHER

collaborator

Hospital Universitario Virgen de la Arrixaca

OTHER

collaborator

Public Health Service, Murcia

OTHER

lead

Red de Terapia Celular

INDUSTRY

NCT01824368 - Extracorporeal Photopheresis in Liver Transplantation. Phase II Clinical Trial in Safety and Efficacy in Patients With Gradual Decrease of Immunosuppression. | Biotech Hunter | Biotech Hunter