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

University of Navarra

Status and phase: Completed; Phase 2; Phase 1

Conditions: Liver Cirrhosis

Treatments: Other: Autologous bone marrow-derived endothelial progenitor cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01333228

EPC/CIRR

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Endothelial Progenitors Cells

Experimental group

Description:

Autologous bone marrow-derived endothelial progenitor cells

Treatment:

Other: Autologous bone marrow-derived endothelial progenitor cells