Extracorporeal Photopheresis in Liver Transplantation. Phase II Clinical Trial in Safety and Efficacy in Patients With Gradual Decrease of Immunosuppression.
NCT ID: NCT01824368
Last Updated: 2017-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
10 participants
INTERVENTIONAL
2013-04-30
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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People with liver transplantation
People with liver transplantation over 2 years following treatment with immunosuppression including cyclosporine or tacrolimus.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Spanish National Health System
OTHER
Universidad de Murcia
OTHER
Hospital Universitario Virgen de la Arrixaca
OTHER
Public Health Service, Murcia
OTHER
Red de Terapia Celular
INDUSTRY
Responsible Party
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Locations
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University Hospital Virgen de la Arrixaca
El Palmar, Murcia, Spain
Countries
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Related Links
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Red de Terapia Celular (TerCel)
Fundación para la Formación e Investigación Sanitarias Región de Murcia
Servicio Murciano de Salud
Other Identifiers
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2012-000633-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
FEC-TH
Identifier Type: -
Identifier Source: org_study_id
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