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

Primary Purpose

Liver Cirrhosis

Status

Completed

Phase

Phase 1

Locations

Spain

Study Type

Interventional

Intervention

Autologous bone marrow-derived endothelial progenitor cells

About this trial

This is an interventional treatment trial for Liver Cirrhosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Clinica Universidad de Navarra

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endothelial Progenitors Cells

Arm Description

Autologous bone marrow-derived endothelial progenitor cells

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Effect on portal hypertension

Changes in Hepatic Venous Pressure Gradient (HVPG) will be used to assess the effect on portal hypertension.

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.

Full Information

NCT ID

NCT01333228

First Posted

April 1, 2011

Last Updated

May 25, 2015

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Collaborators

Foundation Ramon Areces, Instituto de Salud Carlos III

1. Study Identification

Unique Protocol Identification Number

NCT01333228

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Collaborators

Foundation Ramon Areces, Instituto de Salud Carlos III

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Cirrhosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Endothelial Progenitors Cells

Arm Type

Experimental

Arm Description

Autologous bone marrow-derived endothelial progenitor cells

Intervention Type

Other

Intervention Name(s)

Autologous bone marrow-derived endothelial progenitor cells

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Participants with Adverse Events as a Measure of Safety and tolerability

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

12 months

Title

Effect on portal hypertension

Description

Changes in Hepatic Venous Pressure Gradient (HVPG) will be used to assess the effect on portal hypertension.

Time Frame

12 months

Title

Effect on complications of liver cirrhosis

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: