Liver CirrhosisPhase 1/2NCT01333228

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

A Phase 1/2 study testing Autologous bone marrow-derived endothelial progenitor cells in people with Liver Cirrhosis, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Liver Cirrhosis
What is being tested?: Autologous bone marrow-derived endothelial progenitor cells
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteSpain
Study dates: Jun 2012to Mar 2015
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Liver cirrhosis (Child-Pugh 8 or above).
Ability to sign informed consent

Who cannot join

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

Show all 11Show fewer

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 locations and contacts

1 site in 1 country.

Spain1 site

Clinica Universidad de Navarra
Pamplona, Navarre, 31008

Other trials in Spain

About this study

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

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.

Conditions: Liver Cirrhosis
Being tested: Autologous bone marrow-derived endothelial progenitor cells
Medical subject headings: Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01333228
Study group	Role	What they receive
Endothelial Progenitors Cells	Experimental	Autologous bone marrow-derived endothelial progenitor cells Receives: Other: Autologous bone marrow-derived endothelial progenitor cells

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months

Secondary outcomes (3)

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.
Measured: 12 months
Effect on portal hypertension
Changes in Hepatic Venous Pressure Gradient (HVPG) will be used to assess the effect on portal hypertension.
Measured: 12 months
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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012Mar 2015

First posted11 Apr 2011 (estimated)
Study startJun 2012
Primary completionOct 2014
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Liver CirrhosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01333228
Sponsor's protocol ID: EPC/CIRR
Status last verified: May 2015
First submitted: 1 Apr 2011
Last updated: 27 May 2015
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 26972567

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Liver Cirrhosis trials

Study at a glance

From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01333228
Acronym / sponsor ID: EPC/CIRR
Conditions: Liver Cirrhosis
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
Collaborators: Foundation Ramon Areces, Instituto de Salud Carlos III
Study start: Jun 2012
Primary completion: Oct 2014 (actual)
Study completion: Mar 2015 (actual)
First posted: 11 Apr 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Endothelial Progenitors Cells	Experimental	Other: Autologous bone marrow-derived endothelial progenitor cellsAutologous bone marrow-derived endothelial progenitor cells

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Liver cirrhosis (Child-Pugh 8 or above).
Ability to sign informed consent

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Autologous bone marrow-derived endothelial progenitor cellsIntraarterial administration (hepatic artery) of autologous bone marrow-derived endothelial progenitor cells	Other	Endothelial Progenitors Cells

Primary outcome

Number of Participants with Adverse Events as a Measure of Safety and tolerability
Time frame: 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.

3 secondary outcomes

Changes of liver function test as a measure of the effect on liver function
Time frame: 12 months
Effect on portal hypertension
Time frame: 12 months
Effect on complications of liver cirrhosis
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
Derived from this study: PubMed 26972567D'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.
Clinica Universidad de NavarraLink provided by the sponsor.
Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y DigestivasLink provided by the sponsor.

Related trials for Liver Cirrhosis

RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
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Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jorge Quiroga, MD, PhD principal investigator

Liver Unit, Clinica Universidad de Navarra/Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd)(Pamplona-Spain)

Jesus Prieto, MD, PhD study chair

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)

Delia D'Avola, MD study chair

Liver Unit, Clinica Universidad de Navarra/Centro de Investigación Biomédica en Red en el Área temática de Enfermedades Hepáticas y Digestivas (CIBERehd)(Pamplona-Spain)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Autologous bone marrow-derived endothelial progenitor cells in people with Liver Cirrhosis, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events as a Measure of Safety and tolerability (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01333228, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.