Liver Cirrhosis
Conditions
Keywords
Umbilical Mesenchymal Stem Cells; Liver cirrhosis
Brief summary
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.
Interventions
BIOLOGICALmesenchymal stem cells
Conventional therapy plus UC-MSC intravenous administration (4x107/40ml, once per three months, four times in one year)
BIOLOGICALConventional therapy
Conventional therapy without cell therapy
Sponsors
Alliancells Bioscience Corporation Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| survival time | 3-year follow up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum markers regarding lipid and sugar profile | 0, 3, 6, 9 and 12 months | Total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglycerides (TG), very low density lipoprotein cholesterol (VLDL-C), and Non-HDL-C; blood sugar; |
| Serum markers regarding cytokine profile | 0, 3, 6, 9 and 12 months | IL-1β, IL-4, IL-6, IL-8, IL-10, IL-12(p40), IL-15, IL-17A, TNFα, TNFβ, IFN-γ, RANTES, TGFβ, lymphotactin, and C-reactive protein level (CRP) |
| Serum markers regarding liver and kidney function | 0, 3, 6, 9 and 12 months | liver functions：Albumin (ALB), Alanine aminotransferase (ALT), Aspartate Aminotransferase (AST), Prealbumin(PA), total bilirubin (TB), and direct bilirubin (DB) kidney function：Blood urea nitrogen (BUN), Urea (UA), and Crea (Cr) |
| tolerance and the adverse events | 3-year follow up | The classification for uncomfortable reaction is: 0, no discomfort; 1, slightly unwell, does not affect daily life; 2, moderate discomfort, affects daily life and work; 3, moderately unwell, significantly affects life, and bed rest; 4, severely unwell, life-threatening. A serious adverse event is defined as fatal, life threatening, permanently disabling, and tumors, particularly hepatocellular carcinoma. |
| Changes of any clinical symptoms | 3-year follow up | abdominal distension, appetite, debilitation, and edema of lower limbs. |
| Serum levels of Hepatitis B and C | 0, 3, 6, 9 and 12 months | Serum levels of Hepatitis B and C |
Countries
China
Contacts
Primary ContactXuetao Pei, MD,PhD
Backup ContactHaijie Ji, MD
Outcome results
None listed