A randomized clinical trial for evaluating effects of activated donor liver mononuclear cells inoculation on liver transplantation recipients with hepatitis C (HCV).

UMIN ID: UMIN000000538

Registered date:01/01/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Liver transplantation recipients with HCV
• Date of first enrollment: 2007/04/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Participated patients will be randomly divided into two groups. One is cell therapy group and the other is untreated group. Patients in cell therapy group are injected activated donor liver mononuclear cells 3 days after liver transplantation.
Patients in untreated group are injected placebo without cells.

Outcome(s)

• Primary Outcome: 5-year survival rate, and SVR
• Secondary Outcome: Adverse events, Postoperative infectious complication rate, Median overall survival

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Symptomatic infectious disease Fluminant hepatitis ABO incompatible transplantation Retransplantation Decision as ineligible by principal investigators

Related Information

• Primary Sponsor: Department of surgery, division of frontier medical science, programs for biomedical research, Graduate school of biomedical sciences, Hiroshima university
• Source(s) of Monetary Support: Department of surgery, division of frontier medical science, programs for biomedical research, Graduate school of biomedical sciences, Hiroshima university