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Completed

NCT Number: NCT01333228

Evaluate Safety and Efficacy of Autologous Bone Marrow-derived Endothelial Progenitor Cells in 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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous bone marrow-derived endothelial progenitor cells

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Collaborators

  • Foundation Ramon Areces
  • Instituto de Salud Carlos III

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Apr 11, 2011
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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