Safety Study of Autologous Stem Cell in Liver Cirrhosis - Full Text View

Sponsors and Collaborators:	Federal University of Rio de Janeiro FINEP - Research and Projects Financing
Information provided by:	Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier:	NCT00382278

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 I Phase II

MedlinePlus related topics: Cirrhosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase 1/2 Study of Autologous Bone Marrow Derived Mononuclear Cells in Liver Cirrhosis

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:

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:	UFRJ ( Guilherme Ferreira da Motta Rezende )
Study ID Numbers:	CELTHEP-01
Study First Received:	September 28, 2006
Last Updated:	April 2, 2008
ClinicalTrials.gov Identifier:	NCT00382278 History of Changes
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

Study placed in the following topic categories:

Liver Diseases
Digestive System Diseases
Fibrosis
Anesthetics
Liver Cirrhosis

Additional relevant MeSH terms:

Liver Diseases
Pathologic Processes
Digestive System Diseases
Fibrosis
Liver Cirrhosis

ClinicalTrials.gov processed this record on May 07, 2009