Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-31 @ 11:14 AM
Study NCT ID:
NCT01333228
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2011-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate Safety and Efficacy of Autologous Bone Marrow-derived Endothelial Progenitor Cells in Advanced Liver Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-25', 'studyFirstSubmitDate': '2011-04-01', 'studyFirstSubmitQcDate': '2011-04-08', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events as a Measure of Safety and tolerability', 'timeFrame': '12 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Changes of liver function test as a measure of the effect on liver function', 'timeFrame': '12 months', 'description': '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.'}, {'measure': 'Effect on portal hypertension', 'timeFrame': '12 months', 'description': 'Changes in Hepatic Venous Pressure Gradient (HVPG) will be used to assess the effect on portal hypertension.'}, {'measure': 'Effect on complications of liver cirrhosis', 'timeFrame': '12 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Liver Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '26972567', 'type': 'DERIVED', 'citation': "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."}], 'seeAlsoLinks': [{'url': 'http://www.cun.es', 'label': 'Clinica Universidad de Navarra'}, {'url': 'http://www.ciberehd.org', 'label': 'Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Liver cirrhosis (Child-Pugh 8 or above).\n* Ability to sign informed consent\n\nExclusion Criteria:\n\n* Age \\<18 or \\>75\n* Variceal bleeding or severe infection within the past 30 days before screening\n* Chronic encephalopathy preventing the ability to sign informed consent (it could be done by legal representant of the patient) and/or the ability to follow the study protocol\n* Hepatocellular carcinoma (previous or current)\n* Any current or previous malignancy (within 5 years before the inclusion) except "in situ" tumors or skin basal cell carcinomas\n* Any severe extrahepatic disease during the past 30 days before the inclusion\n* Any current decompensated chronic disease\n* Any contraindication for the examinations of the clinical protocol (medullar aspiration, arteriography, HVPG measurement)\n* Any other condition that could negatively affect the compliance with the protocol\n* Pregnant or breast-feeding women\n* Participation in a trial of an experimental drug or device within 30 days before screening'}, 'identificationModule': {'nctId': 'NCT01333228', 'briefTitle': 'Evaluate Safety and Efficacy of Autologous Bone Marrow-derived Endothelial Progenitor Cells in Advanced Liver Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Clinica Universidad de Navarra, Universidad de Navarra'}, 'officialTitle': 'Pilot Clinical Trial (Phase I/II) to Evaluate Safety and Therapeutic Effects of the Administration of Autologous Bone Marrow-derived EPCs in Patients With Advanced Liver Cirrhosis', 'orgStudyIdInfo': {'id': 'EPC/CIRR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endothelial Progenitors Cells', 'description': 'Autologous bone marrow-derived endothelial progenitor cells', 'interventionNames': ['Other: Autologous bone marrow-derived endothelial progenitor cells']}], 'interventions': [{'name': 'Autologous bone marrow-derived endothelial progenitor cells', 'type': 'OTHER', 'description': 'Intraarterial administration (hepatic artery) of autologous bone marrow-derived endothelial progenitor cells', 'armGroupLabels': ['Endothelial Progenitors Cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Clinica Universidad de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}], 'overallOfficials': [{'name': 'Jorge Quiroga, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Liver Unit, Clinica Universidad de Navarra/Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd)(Pamplona-Spain)'}, {'name': 'Jesus Prieto, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': '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)'}, {'name': "Delia D'Avola, MD", 'role': 'STUDY_CHAIR', 'affiliation': 'Liver Unit, Clinica Universidad de Navarra/Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd)(Pamplona-Spain)'}, {'name': 'Jose Ignacio Herrero, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Liver Unit, Clinica Universidad de Navarra/Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd)(Pamplona-Spain)'}, {'name': 'Bruno Sangro, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Liver Unit, Clinica Universidad de Navarra/Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd)(Pamplona-Spain)'}, {'name': 'Veronica Fernandez Ruiz, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Centro de Investigación Medica Aplicada (CIMA)(Pamplona-Spain)'}, {'name': 'Javier Perez Calvo, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hematology, Clinica Universidad de Navarra (Pamplona-Spain)'}, {'name': 'Mercedes Iñarrairaegui, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Liver Unit, Clinica Universidad de Navarra/Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd)(Pamplona-Spain)'}, {'name': 'Jose Ignacio Bilbao, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Radiology, Clinica Universidad de Navarra (Pamplona-Spain)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinica Universidad de Navarra, Universidad de Navarra', 'class': 'OTHER'}, 'collaborators': [{'name': 'Foundation Ramon Areces', 'class': 'UNKNOWN'}, {'name': 'Instituto de Salud Carlos III', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}