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| Name | Class |
|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
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The purpose of this study is to assess the safety and efficacy of injectable collagen scaffold combined with human umbilical cord-derived mesenchymal stem cells (HUC-MSCs) transplantation in patients with Decompensated Cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional therapy | Sham Comparator |
| |
| Injectable Collagen Scaffold + HUC-MSCs | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional therapy | Biological | Patients will receive the conventional therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of liver function measured by change in the model for end-stage liver disease (MELD) score | 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of liver function measured by change in Child-Pugh score | 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention | |
| Change in clinical laboratory parameters of liver function | The liver function tests included serum Albumin (Alb), Cholesterol, Cholinesterase (CHE), prothrombin activity. |
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Inclusion Criteria:
Participants must meet all of the following criteria:
Exclusion Criteria:
Participants CANNOT meet any of the following criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhifeng Xiao, Ph.D | Contact | 86-10-82614420 | zfxiao@genetics.ac.cn | |
| Sufang Han, Ph.D | Contact | 86-10-82614420 | sufanghan22@genetics.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jianwu Dai, Ph.D | Chinese Academy of Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting | Nanjing | Jiangsu | 210008 | China |
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| Injectable Collagen Scaffold + HUC-MSCs | Biological | Injectable collagen scaffold combined with HUC-MSCs was injected into left lateral segment, left medial segment, right anterior segment, right posterior segment and caudate lobe under B-mode ultrasound supervision, respectively. The total amount of HUC-MSCs was 5*10^8. |
|
| 1 day, 3 day, 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention |
| 30-Day Survival | Patients surviving more than 30 days after study registration. | 30 days |
| Change in the size of liver and spleen and inner diameter of spleen portal venous | 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention |