Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mesenchymal stem cells | Biological | Conventional therapy plus UC-MSC intravenous administration (4x107/40ml, once per three months, four times in one year) |
|
| Measure | Description | Time Frame |
|---|---|---|
| survival time | 3-year follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 0, 3, 6, 9 and 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuetao Pei, MD,PhD | Contact | 86-10-68214650 | peixt@nic.bmi.ac.cn | |
| Haijie Ji, MD | Contact | 86-10-63188853 | jihaijie82@sohu.com |
| Name | Affiliation | Role |
|---|---|---|
| Xuetao Pei, MD,PhD | Chinese Industry and Innovative Technology Strategic Alliance of Stem Cells and Regenerative Medicine | Study Chair |
| Yongjun Liu, MD,PhD | Alliancells Bioscience Corporation Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 302 Hospital of Chinese People's Liberation Army | Recruiting | Beijing | Beijing Municipality | China |
Not provided
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Conventional therapy | Biological | Conventional therapy without cell therapy |
|
| 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; |
| 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) | 0, 3, 6, 9 and 12 months |
| Serum levels of Hepatitis B and C | Serum levels of Hepatitis B and C | 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. | 3-year follow up |
| Changes of any clinical symptoms | abdominal distension, appetite, debilitation, and edema of lower limbs. | 3-year follow up |
| Mingyuan Wu, MD,PhD | Eastern Union Stem Cell & Gene Engineering Co.,Ltd, Alliancells Bioscience Corporation Limited | Study Director |
| Hanwei Li, MD,PhD | The 302 Hospital of Chinese People's Liberation Army | Principal Investigator |
| Liming Wang, MD | The 323 Hospital of Chinese People's Liberation Army | Principal Investigator |
| Xun Li, MD,PhD | LanZhou University | Principal Investigator |
| Liming Chen, MD,PhD | ongji Hospital of Tongji University | Principal Investigator |
| Jianwei Lu, MD | Tongji Hospital | Principal Investigator |
| Hui Shi, MD | The First People's Hospital of Lianyungang | Principal Investigator |
| the First Affiliated Hospital of Lanzhou University | Recruiting | Lanzhou | Gansu | China |
|
| Hainan BOAO Life infinity international anti-aging medical center | Recruiting | Qionghai | Hainan | 571434 | China |
|
| The first people's hospital of Lianyungang | Recruiting | Lianyungang | Jiangsu | 222002 | China |
|
| Tongji Hospital of Tongji University | Recruiting | Shanghai | Shanghai Municipality | China |
|
| The 323 Hospital of Chinese People's Liberation Army | Recruiting | Xi’an | Shanxi | 710054 | China |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |