Autologous Bone Marrow Mononuclear Cells in Liver Cirrhosis

Liver Cirrhosis Due to Virus C Chronic Hepatitis Clinical Trial

— CELTHEP-02  

Official title:

Phase 1 Study of Autologous Bone Marrow Mononuclear Cells Infusion in Peripheral Vein in Liver Cirrhosis Due to Hepatitis C Virus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00832247
• Other study ID #: CELTHEP-02
• Status: Recruiting
• Phase: Phase 1
• First received: January 29, 2009
• Last updated: January 29, 2009
• Start date: January 2009
• Est. completion date: April 2010

Study information

• Verified date: January 2009
• Source: Universidade Federal do Rio de Janeiro
• Contact: Guilherme FM Rezende, MD PhD
• Phone: 55-21-99976292
• Email: g.rezende[@]superig.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

This is a phase I clinical study to evaluate feasibility, safety and kinetics of cellular therapy with autologous bone marrow-derived mononuclear cells (BMMC) in patients with liver cirrhosis due to virus C hepatitis. Another aim is to study liver tissue changes induced by the BMMC presence. All the patients have moderate liver disfunction and will be submitted to a liver biopsy before BMMC injection. The cells will be labeled with 99mTc and infused through a peripheral vein. Scintigraphy will be performed 24 hours after infusion.

Patients will be submitted to frequent clinical, laboratorial and image evaluation during a one-year follow-up. A second liver biopsy will be done in the 3rd month after infusion to check histological, cellular and molecular evolutive changes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Chronic virus C hepatitis

• Liver cirrhosis

• Moderate liver disfunction

Exclusion Criteria:

• Malignant disease

• Pregnancy

• Significant comorbidity

• Portal vein thrombosis

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Liver Cirrhosis
• Liver Cirrhosis Due to Virus C Chronic Hepatitis

Intervention

Genetic:
• Autologous bone marrow mononuclear cells infusion
At least 100.000.000 autologous BMMC will be infused in a peripheral vein once suspended in albumine during 10 minutes

Locations

Country	Name	City	State
Brazil	Hospital Universitário Clementino Fraga Filho	Rio de Janeiro	RJ

Sponsors (6)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Financiadora de Estudos e Projetos, Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ), Oswaldo Cruz Foundation, University of Edinburgh

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver function worsening		One year	Yes
Secondary	Liver related mortality		One year	Yes
Secondary	Hepatocellular carcinoma development accessed by ultrasound and CT scan		One year	Yes
Secondary	BMMC kinetics accessed by total body scintigraphy		24 hours	No
Secondary	Liver tissue changes evaluated by histopathology analysis and molecular biology		10 weeks	No