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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000633-39 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extracorporeal Photopheresis | Experimental | Extracorporeal Photopheresis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal photopheresis | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events associated with the procedure | 12 months | |
| Non Serious Adverse Events | 12 months | |
| Allograft Rejection | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunosuppressant level | CyA, tacrolimus levels | 12 months |
| Liver function test | Total protein, albumin, bilirubin, GOT, GPT, alkaline phosphatase, gamma- GT, Quick index. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Antonio Pons, MD | Hospital ClÃnco Universitario Virgen de la Arrixaca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jose Antonio Pons, MD | Murcia | El Palmar | 30120 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12698096 | Background | Pons JA, Yelamos J, Ramirez P, Oliver-Bonet M, Sanchez A, Rodriguez-Gago M, Navarro J, Bermejo J, Robles R, Parrilla P. Endothelial cell chimerism does not influence allograft tolerance in liver transplant patients after withdrawal of immunosuppression. Transplantation. 2003 Apr 15;75(7):1045-7. doi: 10.1097/01.TP.0000058472.71775.7D. | |
| 19210687 |
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| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D017893 | Photopheresis |
| ID | Term |
|---|---|
| D011701 | PUVA Therapy |
| D014467 | Ultraviolet Therapy |
| D010789 | Phototherapy |
| D013812 | Therapeutics |
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|
| 12 months |
| Renal Function test | Creatinine, urea, glomerular filtration rate (MDRD), creatinine clearance | 12 months |
| Hematological Parameters | Basic hematological parameters: Hemoglobin, hematocrit, platelets and leukocytes. Metabolic parameters: Glucose, uric acid, triglycerides, cholesterol, HDL and LDL cholesterol. | 12 months |
| Immunological evaluation | 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 | 12 months |
| Pons JA, Ramirez P, Revilla-Nuin B, Pascual D, Baroja-Mazo A, Robles R, Sanchez-Bueno F, Martinez L, Parrilla P. Immunosuppression withdrawal improves long-term metabolic parameters, cardiovascular risk factors and renal function in liver transplant patients. Clin Transplant. 2009 Jun-Jul;23(3):329-36. doi: 10.1111/j.1399-0012.2008.00944.x. Epub 2009 Feb 5. |
| 19034005 | Background | Pons JA, Revilla-Nuin B, Baroja-Mazo A, Ramirez P, Martinez-Alarcon L, Sanchez-Bueno F, Robles R, Rios A, Aparicio P, Parrilla P. FoxP3 in peripheral blood is associated with operational tolerance in liver transplant patients during immunosuppression withdrawal. Transplantation. 2008 Nov 27;86(10):1370-8. doi: 10.1097/TP.0b013e318188d3e6. |
| D005112 |
| Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |