Title

Safety and Efficacy Study of Umbilical Mesenchymal Stem Cells for Liver Cirrhosis
Clinical Trial of Umbilical Mesenchymal Stem Cells Transplantation for Liver Cirrhosis-Phase I/II
  • Phase

    Phase 1/Phase 2
  • Study Type

    Interventional
  • Status

    Unknown status
  • Study Participants

    320
Liver cirrhosis and subsequent liver failure are leading causes of morbidity and mortality worldwide. Alcohol abuse and viral hepatitis are the most common causes of cirrhosis. Novel therapies are necessary to prevent or block the process of the disease. In this current prospective cohort, the investigators plan to organize four hospitals to determine the safety and efficacy of intravenous administration of umbilical mesenchymal stem cells in the treatment of patients with liver cirrhosis in next three years.
Study Started
Jul 31
2014
Primary Completion
Jul 31
2015
Anticipated
Study Completion
Oct 31
2015
Anticipated
Last Update
Apr 14
2015
Estimate

Biological mesenchymal stem cells

Conventional therapy plus UC-MSC intravenous administration (4x107/40ml, once per three months, four times in one year)

Biological Conventional therapy

Conventional therapy without cell therapy

Conventional therapy Sham Comparator

only apply for conventional medical therapy without any cell therapy

mesenchymal stem cells Active Comparator

combination of conventional therapy with umbilical mesenchymal stem cells intravenous injection, (4x107/40ml, once per three months, four times in one year)

Criteria

Inclusion Criteria:

written informed consent
aged 30-60 years
clinical diagnosis of compensated or decompensated liver
child-Pugh B/C (7-12 points)
expecting lifetime is over three years

Exclusion Criteria:

pregnant woman
patient with severe vascular diseases
patient with any organ failure
patient with any tumors
patient with HIV
patient who has been transplanted
patient treated with immunosuppressors
patient for whom the follow-up is considered impossible
patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
No Results Posted