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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000633-39 | EudraCT Number |
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| Name | Class |
|---|---|
| Spanish National Health System | OTHER |
| Universidad de Murcia | OTHER |
| Hospital Universitario Virgen de la Arrixaca | OTHER |
| Public Health Service, Murcia |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People with liver transplantation | Experimental | People with liver transplantation over 2 years following treatment with immunosuppression including cyclosporine or tacrolimus. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal Photopheresis Procedure (FEC) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| adverse event rate and rate of transplant rejection | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Virgen de la Arrixaca | El Palmar | Murcia | 30120 | Spain |
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| Label | URL |
|---|---|
| Red de Terapia Celular (TerCel) | View source |
| Fundación para la Formación e Investigación Sanitarias Región de Murcia | View source |
| Servicio Murciano de Salud |
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| OTHER |
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| ID | Term |
|---|---|
| C052498 | FEC protocol |
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