Safety and Efficacy Study of Umbilical Mesenchymal Stem Cells for Liver Cirrhosis (LC)

Alliancells Bioscience

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Liver Cirrhosis

Treatments: Biological: Conventional therapy; Biological: mesenchymal stem cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT01573923

Alliancells-2012-1

Details and patient eligibility

About

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.

Enrollment: 320 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

Conventional therapy

Sham Comparator group

Description:

only apply for conventional medical therapy without any cell therapy

Treatment:

Biological: Conventional therapy

mesenchymal stem cells

Active Comparator group

Description:

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

Treatment:

Biological: mesenchymal stem cells