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| Name | Class |
|---|---|
| Foundation Ramon Areces | UNKNOWN |
| Instituto de Salud Carlos III | OTHER_GOV |
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Endothelial Progenitor Cells (EPC) represent a small cellular population of bone marrow and peripheral blood cells. EPCs are recruited into injured tissues and play an important role in regeneration and reparation. Experimental and clinical data suggest that EPCs have hepatoprotective activity and could improve liver regeneration during acute and chronic liver injury. The aim of this project is to evaluate the safety and therapeutic effects of autologous bone marrow-derived EPCs, when administered through the hepatic artery of patients with advanced liver cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endothelial Progenitors Cells | Experimental | Autologous bone marrow-derived endothelial progenitor cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous bone marrow-derived endothelial progenitor cells | Other | Intraarterial administration (hepatic artery) of autologous bone marrow-derived endothelial progenitor cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and tolerability | The safety of the administration of autologous bone marrow-derived EPC in patients with advanced cirrhosis will be evaluated by anamnesis, physical examination, hematological and biochemical variables and imaging examination. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of liver function test as a measure of the effect on liver function | Determination of liver function test (aminotransferases,albumin, bilirubin and protrombin time) and calculation of Model for End-Stage Liver Disease (MELD) and Chil-Pugh scores. Differences in these variables compared to baseline will be considered as a measure of the effect on liver function. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorge Quiroga, MD, PhD | Liver Unit, Clinica Universidad de Navarra/Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd)(Pamplona-Spain) | Principal Investigator |
| Jesus Prieto, MD, PhD | Liver Unit, Clinica Universidad de Navarra/Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd)/Centro de Investigación Medica Aplicada (CIMA)(Pamplona-Spain) | Study Chair |
| Delia D'Avola, MD | Liver Unit, Clinica Universidad de Navarra/Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd)(Pamplona-Spain) | Study Chair |
| Jose Ignacio Herrero, MD, PhD | Liver Unit, Clinica Universidad de Navarra/Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd)(Pamplona-Spain) | Study Chair |
| Bruno Sangro, MD, PhD | Liver Unit, Clinica Universidad de Navarra/Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd)(Pamplona-Spain) | Study Chair |
| Veronica Fernandez Ruiz, PhD | Centro de Investigación Medica Aplicada (CIMA)(Pamplona-Spain) | Study Chair |
| Javier Perez Calvo, MD,PhD | Hematology, Clinica Universidad de Navarra (Pamplona-Spain) |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Universidad de Navarra | Pamplona | Navarre | 31008 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26972567 | Derived | D'Avola D, Fernandez-Ruiz V, Carmona-Torre F, Mendez M, Perez-Calvo J, Prosper F, Andreu E, Herrero JI, Inarrairaegui M, Fuertes C, Bilbao JI, Sangro B, Prieto J, Quiroga J. Phase 1-2 pilot clinical trial in patients with decompensated liver cirrhosis treated with bone marrow-derived endothelial progenitor cells. Transl Res. 2017 Oct;188:80-91.e2. doi: 10.1016/j.trsl.2016.02.009. Epub 2016 Feb 24. |
| Label | URL |
|---|---|
| Clinica Universidad de Navarra | View source |
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| Effect on portal hypertension | Changes in Hepatic Venous Pressure Gradient (HVPG) will be used to assess the effect on portal hypertension. | 12 months |
| Effect on complications of liver cirrhosis | Ascitis grade, episodes of upper gastrointestinal bleeding as well as of episodes of hepatic encephalopathy will be used as a measure of the effect of the treatment on the complications of liver cirrhosis. | 12 months |
| Study Chair |
| Mercedes Iñarrairaegui, MD PhD | Liver Unit, Clinica Universidad de Navarra/Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd)(Pamplona-Spain) | Study Chair |
| Jose Ignacio Bilbao, MD,PhD | Radiology, Clinica Universidad de Navarra (Pamplona-Spain) | Study Chair |
| Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas | View source |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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