ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety Study of Autologous Stem Cell in Liver Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00382278
Recruitment Status : 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.)
First Posted : September 29, 2006
Last Update Posted : April 3, 2008
Sponsor:
Collaborator:
Financiadora de Estudos e Projetos
Information provided by:
Universidade Federal do Rio de Janeiro

Brief 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.

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

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Study of Autologous Bone Marrow Derived Mononuclear Cells in Liver Cirrhosis
Study Start Date : November 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources


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.


Primary Outcome Measures :
  1. 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 ]
  2. Hepatic artery and portal vein thrombosis (doppler ultrasound) [ Time Frame: in days 1,2,7,14,90, 180 and 360 ]
  3. 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 ) ]
  4. Liver related mortality [ Time Frame: 360 days ]

Secondary Outcome Measures :
  1. Body distribution of 99mTc labeled BMDMC (scintigraphy) [ Time Frame: after 3 hours of infusion ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00382278


Locations
Brazil
Hospital Universitário Clementino Fraga Filho
Rio de Janeiro, Brazil, 21941-590
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Financiadora de Estudos e Projetos
Investigators
Principal Investigator: Guilherme FM Rezende, MD, PhD Universidade Federal do Rio de Janeiro

Responsible Party: Guilherme Ferreira da Motta Rezende, UFRJ
ClinicalTrials.gov Identifier: NCT00382278     History of Changes
Other Study ID Numbers: CELTHEP-01
First Posted: September 29, 2006    Key Record Dates
Last Update Posted: April 3, 2008
Last Verified: February 2008

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

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