Evaluate Safety and Efficacy of Autologous Bone Marrow-derived Endothelial Progenitor Cells in Advanced Liver Cirrhosis
- Conditions
- Liver Cirrhosis
- Interventions
- Other: Autologous bone marrow-derived endothelial progenitor cells
- Registration Number
- NCT01333228
- Lead Sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
- Liver cirrhosis (Child-Pugh 8 or above).
- Ability to sign informed consent
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Endothelial Progenitors Cells Autologous bone marrow-derived endothelial progenitor cells Autologous bone marrow-derived endothelial progenitor cells
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events as a Measure of Safety and tolerability 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 Outcome Measures
Name Time Method Effect on complications of liver cirrhosis 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.
Effect on portal hypertension 12 months Changes in Hepatic Venous Pressure Gradient (HVPG) will be used to assess the effect on portal hypertension.
Changes of liver function test as a measure of the effect on liver function 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.
Trial Locations
- Locations (1)
Clinica Universidad de Navarra
🇪🇸Pamplona, Navarra, Spain