Clinical trial NCT01333228: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Liver Cirrhosis
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
Collaborators: name: Foundation Ramon Areces
name: Instituto de Salud Carlos III
First posted: 2011-04-11
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and tolerability
timeFrame: 12 months
Secondary outcomes:
measure: Changes of liver function test as a measure of the effect on liver function
timeFrame: 12 months
measure: Effect on portal hypertension
timeFrame: 12 months
measure: Effect on complications of liver cirrhosis
timeFrame: 12 months
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
Study officials:
affiliation: Liver Unit, Clinica Universidad de Navarra/Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd)(Pamplona-Spain)
name: Jorge Quiroga, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Liver Unit, Clinica Universidad de Navarra/Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd)/Centro de Investigación Medica Aplicada (CIMA)(Pamplona-Spain)
name: Jesus Prieto, MD, PhD
role: STUDY_CHAIR
affiliation: Liver Unit, Clinica Universidad de Navarra/Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd)(Pamplona-Spain)
name: Delia D'Avola, MD
role: STUDY_CHAIR
affiliation: Liver Unit, Clinica Universidad de Navarra/Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd)(Pamplona-Spain)
name: Jose Ignacio Herrero, MD, PhD
role: STUDY_CHAIR
affiliation: Liver Unit, Clinica Universidad de Navarra/Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd)(Pamplona-Spain)
name: Bruno Sangro, MD, PhD
role: STUDY_CHAIR
affiliation: Centro de Investigación Medica Aplicada (CIMA)(Pamplona-Spain)
name: Veronica Fernandez Ruiz, PhD
role: STUDY_CHAIR
affiliation: Hematology, Clinica Universidad de Navarra (Pamplona-Spain)
name: Javier Perez Calvo, MD,PhD
role: STUDY_CHAIR
affiliation: Liver Unit, Clinica Universidad de Navarra/Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd)(Pamplona-Spain)
name: Mercedes Iñarrairaegui, MD PhD
role: STUDY_CHAIR
affiliation: Radiology, Clinica Universidad de Navarra (Pamplona-Spain)
name: Jose Ignacio Bilbao, MD,PhD
role: STUDY_CHAIR
References:
citation: D'Avola D, Fernandez-Ruiz V, Carmona-Torre F, Mendez M, Perez-Calvo J, Prosper F, Andreu E, Herrero JI, Inarrairaegui M, Fuertes C, Bilbao JI, Sangro B, Prieto J, Quiroga J. Phase 1-2 pilot clinical trial in patients with decompensated liver cirrhosis treated with bone marrow-derived endothelial progenitor cells. Transl Res. 2017 Oct;188:80-91.e2. doi: 10.1016/j.trsl.2016.02.009. Epub 2016 Feb 24.