Evaluate Safety and Efficacy of Autologous Bone Marrow-derived Endothelial Progenitor Cells in Advanced Liver Cirrhosis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Foundation Ramon Areces
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT01333228
First received: April 1, 2011
Last updated: May 20, 2014
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Liver Cirrhosis
Other: Autologous bone marrow-derived endothelial progenitor cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Clinica Universidad de Navarra, Universidad de Navarra:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and tolerability [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Changes of liver function test as a measure of the effect on liver function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Effect on portal hypertension [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Changes in Hepatic Venous Pressure Gradient (HVPG) will be used to assess the effect on portal hypertension.

  • Effect on complications of liver cirrhosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: June 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endothelial Progenitors Cells
Autologous bone marrow-derived endothelial progenitor cells
Other: Autologous bone marrow-derived endothelial progenitor cells
Intraarterial administration (hepatic artery) of autologous bone marrow-derived endothelial progenitor cells

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Liver cirrhosis (Child-Pugh 8 or above).
  • Ability to sign informed consent

Exclusion Criteria:

  • Age <18 or >75
  • Variceal bleeding or severe infection within the past 30 days before screening
  • 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
  • Hepatocellular carcinoma (previous or current)
  • Any current or previous malignancy (within 5 years before the inclusion) except "in situ" tumors or skin basal cell carcinomas
  • Any severe extrahepatic disease during the past 30 days before the inclusion
  • Any current decompensated chronic disease
  • Any contraindication for the examinations of the clinical protocol (medullar aspiration, arteriography, HVPG measurement)
  • Any other condition that could negatively affect the compliance with the protocol
  • Pregnant or breast-feeding women
  • Participation in a trial of an experimental drug or device within 30 days before screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333228

Locations
Spain
Clinica Universidad de Navarra
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Foundation Ramon Areces
Investigators
Principal Investigator: 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)
Study Chair: 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)
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)
  More Information

Additional Information:
No publications provided

Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT01333228     History of Changes
Other Study ID Numbers: EPC/CIRR
Study First Received: April 1, 2011
Last Updated: May 20, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014