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

May 25, 2015 updated by: Clinica Universidad de Navarra, Universidad de Navarra

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universidad de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events as a Measure of Safety and tolerability
Time Frame: 12 months
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of liver function test as a measure of the effect on liver function
Time Frame: 12 months
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
Effect on portal hypertension
Time Frame: 12 months
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
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Collaborators

Instituto de Salud Carlos III
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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

April 1, 2011

First Submitted That Met QC Criteria

April 8, 2011

First Posted (Estimate)

April 11, 2011

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 25, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPC/CIRR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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