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Safety Study of Autologous Stem Cell in Liver Cirrhosis

This study has been terminated.
(Other authors showed the same metabolic effect may be obtained when BMMC are delivered peripherally, with lower risk and cost than through hepatic artery.)
Sponsor:
Collaborator:
FINEP - Research and Projects Financing
Information provided by:
Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT00382278
First received: September 28, 2006
Last updated: April 2, 2008
Last verified: February 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Liver Cirrhosis
 Procedure: Autologous bone marrow-derived mononuclear cells infusion
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1/2 Study of Autologous Bone Marrow Derived Mononuclear Cells in Liver Cirrhosis

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Further study details as provided by Federal University of Rio de Janeiro:

Primary Outcome Measures:
  • Changes in liver function according to Child-Pugh and MELD scores [ Time Frame: in days 1,2,7,14,30, 45, 60, 90, 120, 150, 180, 270, 360 ] [ Designated as safety issue: Yes ]
  • Hepatic artery and portal vein thrombosis (doppler ultrasound) [ Time Frame: in days 1,2,7,14,90, 180 and 360 ] [ Designated as safety issue: Yes ]
  • Development of liver nodule (ultrasound screening) [ Time Frame: in days 1,2,7,14,90, 180 and 360 (US) and in day 360 (CT scan ) ] [ Designated as safety issue: Yes ]
  • Liver related mortality [ Time Frame: 360 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Body distribution of 99mTc labeled BMDMC (scintigraphy) [ Time Frame: after 3 hours of infusion ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: November 2005
Study Completion Date: February 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
Detailed Description:

A one year clinical trial was conducted. Patients had moderate liver dysfunction and a liver transplant was not expected to occur earlier than 12 months, due to low MELD scores. Hepatocellular carcinoma (HCC) and hepatic artery or portal vein thrombosis were excluded by color Doppler ultrasonography (DUS) and 3-phase computed tomography (CT). 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. ABMMC were delivered preferentially in the common hepatic artery by celiac trunk catheterism. Total body scintigraphy (TBS) was performed 3 hours after infusion. Patients were submitted to frequent clinical, biochemical and imaging evaluation during follow up.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Liver cirrhosis of any origin
  • Moderate liver disfunction (Child-Pugh Score=7-10)

Exclusion Criteria:

  • Waiting time expectancy of liver transplant shorter than 12 months
  • Ongoing hepatic encephalopathy
  • Clinically detectable ascitis
  • Severe coagulation disorder (INR>2,0 or platelets count < 40.000)
  • Diagnosis or strong suspicion of cancer (except basocellular)
  • Pregnancy or intention to become pregnant during the next 12 months
  • Moderate or severe co-morbidity
  • Current participation in another clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382278

Locations
Brazil
Hospital Universitário Clementino Fraga Filho
Rio de Janeiro, Brazil, 21941-590
Sponsors and Collaborators
Federal University of Rio de Janeiro
FINEP - Research and Projects Financing
Investigators
Principal Investigator: Guilherme FM Rezende, MD, PhD Federal University of Rio de Janeiro
  More Information

No publications provided

Responsible Party: Guilherme Ferreira da Motta Rezende, UFRJ
ClinicalTrials.gov Identifier: NCT00382278     History of Changes
Other Study ID Numbers: CELTHEP-01
Study First Received: September 28, 2006
Last Updated: April 2, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Rio de Janeiro:
Stem cell
Liver cirrhosis
Cellular therapy
Autologous
Bone marrow

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013