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Safety Study of Autologous Stem Cell in Liver Cirrhosis

NCT00382278 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2008-04-03

No results posted yet for this study

Summary

It is a fase I/II clinical study to evaluate feasibility, safety and kinetics of cellular therapy with bone marrow-derived mononuclear cells (ABMMC) in patients with liver cirrhosis. All the patients have moderate liver disfunction and a waiting time expectancy of liver transplantation longer than 12 months due their low MELD score. The ABMMC are labeled with 99mTc and infused through the hepatic artery. Scintigraphy is performed 2 and 24 hours after infusion. Patients are submitted to frequent clinical, laboratorial and image evaluation during the follow up period of 12 months.

Conditions

Interventions

PROCEDURE

Autologous bone marrow-derived mononuclear cells infusion

Under local anesthesia, 100 mL of bone marrow were aspirated from the posterior iliac crest. ABMMC were isolated by density gradient centrifugation in Ficoll-Hypaque gradient, 10% of the cells were labeled with SnCl2-99mTc, and a small fraction was used for cell counting and viability analysis. At least 100 millions of mononuclear-enriched BMC suspended in 20 mL of saline were delivered preferentially in the common hepatic artery by celiac trunk catheterism.

Sponsors & Collaborators

  • Financiadora de Estudos e Projetos

    collaborator OTHER

  • Universidade Federal do Rio de Janeiro

    lead OTHER

Principal Investigators

  • Guilherme FM Rezende, MD, PhD · Universidade Federal do Rio de Janeiro

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2007-12-31
Completion
2008-02-29

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00382278 on ClinicalTrials.gov