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

Liver Cirrhosis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01333228
• Other study ID #: EPC/CIRR
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 1, 2011
• Last updated: May 25, 2015
• Start date: June 2012
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cirrhosis

Intervention

Other:
• Autologous bone marrow-derived endothelial progenitor cells
Intraarterial administration (hepatic artery) of autologous bone marrow-derived endothelial progenitor cells

Locations

Country	Name	City	State
Spain	Clinica Universidad de Navarra	Pamplona	Navarra

Sponsors (3)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra	Foundation Ramon Areces, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Changes of liver function test as a measure of the effect on liver function	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	No
Secondary	Effect on portal hypertension	Changes in Hepatic Venous Pressure Gradient (HVPG) will be used to assess the effect on portal hypertension.	12 months	No
Secondary	Effect on complications of liver cirrhosis	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	No

External Links

•   Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas
•   Centro de Investigación Medica Aplicada (CIMA)
•   Clinica Universidad de Navarra