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

NCT01333228 | Completed Phase 1

• 1 other identifier: EPC/CIRR
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Changes of liver function test as a measure of the effect on liver function

  12 months

• Effect on portal hypertension

  12 months

• Effect on complications of liver cirrhosis

  12 months

Study Arms (1)

Endothelial Progenitors Cells

EXPERIMENTAL

Autologous bone marrow-derived endothelial progenitor cells

Other: Autologous bone marrow-derived endothelial progenitor cells

Interventions

Autologous bone marrow-derived endothelial progenitor cells OTHER

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

Endothelial Progenitors Cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• Foundation Ramon Areces: collaborator
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (1)

• 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.

  PMID: 26972567 DERIVED

Related Links

• Clinica Universidad de Navarra
• Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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)

  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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2011
• First Posted: April 11, 2011
• Study Start: June 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: March 1, 2015
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

ES (1)