Safety and Efficacy Study of Umbilical Mesenchymal Stem Cells for Liver Cirrhosis
- Conditions
- Liver Cirrhosis
- Interventions
- Biological: mesenchymal stem cellsBiological: Conventional therapy
- Registration Number
- NCT01573923
- Lead Sponsor
- Alliancells Bioscience Corporation Limited
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 320
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mesenchymal stem cells mesenchymal stem cells combination of conventional therapy with umbilical mesenchymal stem cells intravenous injection, (4x107/40ml, once per three months, four times in one year) Conventional therapy Conventional therapy only apply for conventional medical therapy without any cell therapy
- Primary Outcome Measures
Name Time Method survival time 3-year follow up
- Secondary Outcome Measures
Name Time Method 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)
Serum levels of Hepatitis B and C 0, 3, 6, 9 and 12 months Serum levels of Hepatitis B and C
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.
Trial Locations
- Locations (6)
the First Affiliated Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
Hainan BOAO Life infinity international anti-aging medical center
🇨🇳Qionghai, Hainan, China
The 302 Hospital of Chinese People's Liberation Army
🇨🇳Beijing, Beijing, China
The first people's hospital of Lianyungang
🇨🇳Lianyungang, Jiangsu, China
Tongji Hospital of Tongji University
🇨🇳Shanghai, Shanghai, China
The 323 Hospital of Chinese People's Liberation Army
🇨🇳Xi'an, Shanxi, China