NCT02171949

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of multiple infusions of mononuclear bone marrow cells in patients with chronic liver diseases.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

November 28, 2017

Status Verified

November 1, 2017

Enrollment Period

3.7 years

First QC Date

June 16, 2014

Last Update Submit

November 27, 2017

Conditions

Chronic HepatitisHepatic Cirrhosis

Keywords

Chronic hepatitisHepatic cirrhosis

Outcome Measures

Primary Outcomes (2)

  • Evaluation of Child-Pugh score

    Functional class improvement of 2 points on Child-Pugh score.

    12 months

  • Evaluation of MELD score

    Functional class improvement of 2 points on MELD score.

    12 months

Secondary Outcomes (9)

  • Degree of muscle strength

    12 months

  • Hepatic fibrosis

    12 months

  • Quality of life

    12 months

  • Evaluation of functional capacity

    12 months

  • Evaluation of serum bilirubin levels

    12 months

  • +4 more secondary outcomes

Study Arms (2)

Control group

NO INTERVENTION

Bone marrow mononuclear cell therapy

ACTIVE COMPARATOR
Biological: Infusion of bone marrow mononuclear cells.

Interventions

Infusion of bone marrow mononuclear cells.BIOLOGICAL

Patients on this group will receive therapy with mononuclear cells. The cells will be diluted on saline and then injected on the hepatic artery through femoral artery puncture.

Bone marrow mononuclear cell therapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of liver cirrhosis of different etiologies, confirmed by clinical examination, laboratory tests, imaging studies and / or biopsy that shows process of evolution to cirrhosis or established cirrhosis (equivalent to Metavir score F3/F4);
  • Non-participation on the waiting list for liver transplantation or, in case of participation, allocation after the fifth position in the list, for subjects with blood group A or O, and after the third position for subjects with other blood groups;
  • Absence of clinical, laboratory and radiological evidence of hepatocellular carcinoma;
  • Absence of pregnancy potential or negative pregnancy test for female patients, or impossibility to use a contraception method during the study;
  • Permission for doing the puncture of iliac crest after evaluation of pre-anesthetic visit.

You may not qualify if:

  • Impossibility to obtain vascular access for percutaneous procedure;
  • Sepsis;
  • Hepatic encephalopathy detected at the screening tests;
  • Budd-Chiari syndrome;
  • Severe coagulopathy with INR \> 2,4 or platelet count \< 30.000;
  • Presence of malignancies (excluding non-melanoma skin cancer);
  • Decompensated heart failure;
  • Primary hematologic diseases;
  • Renal failure with creatinin \> 2,5mg/dl;
  • Coinfection with HIV;
  • Pregnancy;
  • Dependence of organic medium such as circulatory or ventilatory;
  • Any other comorbidity with an impact on the survival in 2 years;
  • Participation in other clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital São Rafael

Salvador, Estado de Bahia, 41253-190, Brazil

RECRUITING

MeSH Terms

Conditions

Hepatitis, ChronicLiver Cirrhosis

Condition Hierarchy (Ancestors)

HepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsFibrosis

Study Officials

  • André C Lyra, PhD

    Hospital São Rafael

    PRINCIPAL INVESTIGATOR

  • Bruno SF Souza, MD, Msc

    Hospital São Rafael

    STUDY CHAIR

  • Eduardo L Braga, PhD

    Hospital São Rafael

    STUDY CHAIR

  • Lourianne N Cavalcante, PhD

    Hospital São Rafael

    STUDY CHAIR

  • Milena BP Soares, PhD

    Hospital São Rafael

    STUDY CHAIR

  • Ricardo R dos Santos, PhD

    Hospital São Rafael

    PRINCIPAL INVESTIGATOR

  • Ticiana F Larocca, MD, Msc

    Hospital São Rafael

    STUDY CHAIR

Central Study Contacts

André C Lyra, PhD

CONTACT

557132816455aclyra@live.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 16, 2014

First Posted

June 24, 2014

Study Start

April 1, 2015

Primary Completion

December 1, 2018

Study Completion

June 1, 2019

Last Updated

November 28, 2017

Record last verified: 2017-11

Locations

BR(1)