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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
320
Conventional therapy plus UC-MSC intravenous administration (4x107/40ml, once per three months, four times in one year)
Conventional therapy without cell therapy
The 302 Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, China
RECRUITINGthe First Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, China
RECRUITINGHainan BOAO Life infinity international anti-aging medical center
Qionghai, Hainan, China
survival time
Time frame: 3-year follow up
Serum markers regarding liver and kidney function
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)
Time frame: 0, 3, 6, 9 and 12 months
Serum markers regarding lipid and sugar profile
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;
Time frame: 0, 3, 6, 9 and 12 months
Serum markers regarding cytokine profile
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)
Time frame: 0, 3, 6, 9 and 12 months
Serum levels of Hepatitis B and C
Serum levels of Hepatitis B and C
Time frame: 0, 3, 6, 9 and 12 months
tolerance and the adverse events
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.
Time frame: 3-year follow up
Changes of any clinical symptoms
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The first people's hospital of Lianyungang
Lianyungang, Jiangsu, China
RECRUITINGTongji Hospital of Tongji University
Shanghai, Shanghai Municipality, China
RECRUITINGThe 323 Hospital of Chinese People's Liberation Army
Xi’an, Shanxi, China
RECRUITINGabdominal distension, appetite, debilitation, and edema of lower limbs.
Time frame: 3-year follow up