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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Liver Cirrhosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endothelial Progenitors Cells

Autologous bone marrow-derived endothelial progenitor cells

Group Type EXPERIMENTAL

Autologous bone marrow-derived endothelial progenitor cells

Intervention Type OTHER

Intraarterial administration (hepatic artery) of autologous bone marrow-derived endothelial progenitor cells

Interventions

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Autologous bone marrow-derived endothelial progenitor cells

Intraarterial administration (hepatic artery) of autologous bone marrow-derived endothelial progenitor cells

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jorge Quiroga, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Liver Unit, Clinica Universidad de Navarra/Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd)(Pamplona-Spain)

Jesus Prieto, MD, PhD

Role: STUDY_CHAIR

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)

Delia D'Avola, MD

Role: STUDY_CHAIR

Liver Unit, Clinica Universidad de Navarra/Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd)(Pamplona-Spain)

Jose Ignacio Herrero, MD, PhD

Role: STUDY_CHAIR

Liver Unit, Clinica Universidad de Navarra/Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd)(Pamplona-Spain)

Bruno Sangro, MD, PhD

Role: STUDY_CHAIR

Liver Unit, Clinica Universidad de Navarra/Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd)(Pamplona-Spain)

Veronica Fernandez Ruiz, PhD

Role: STUDY_CHAIR

Centro de Investigación Medica Aplicada (CIMA)(Pamplona-Spain)

Javier Perez Calvo, MD,PhD

Role: STUDY_CHAIR

Hematology, Clinica Universidad de Navarra (Pamplona-Spain)

Mercedes Iñarrairaegui, MD PhD

Role: STUDY_CHAIR

Liver Unit, Clinica Universidad de Navarra/Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd)(Pamplona-Spain)