Allogenic Bone Marrow Stem Cells Transplantation in Patients With Liver Cirrhosis

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01223664
• Date of registration: 12/10/2010
• Primary sponsor: Sun Yat-sen University
• Public title: Allogenic Bone Marrow Stem Cells Transplantation in Patients With Liver Cirrhosis
• Scientific title: The Efficacy of Allogenic Bone Marrow Stem Cells Transplantation in Patients With Liver Cirrhosis Resulting From Chronic Hepatitis B
• Date of first enrolment: October 2010
• Target sample size: 60
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01223664
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

China

Contacts

• Name: Lin B Liang, MD/PHD
• Affiliation: SunYat-sen University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Aged 16~65 years.

- Serum HBsAg positive for over six months.

- Ultrasonographic evidences of cirrhosis

Exclusion Criteria:

- History of moderate to severe hepatic encephalopathy or variceal bleeding during the
last two months before enrolment.

- Prothrombin time is over 30s.

- Cirrhosis caused by other reasons except HBV infection.

- Severe problems in other vital organs(e.g.the heart,renal or lungs).

- Liver tumor on ultrasonography, CT or MRI examination.

- Pregnant or lactating women.

- Imaging evidences of vascular thromboses.



Age minimum: 16 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Liver Cirrhosis

Intervention(s)

Drug: Conserved therapy

Procedure: Allogenic bone marrow stem cells transplantation

Primary Outcome(s)

Liver Function [Time Frame: 12 months]

Secondary Outcome(s)

Immunity [Time Frame: 12 months]

Secondary ID(s)

SYS-1012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors