Liver Cirrhosis Clinical Trial
Official title:
The Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion Via Hepatic Artery in Cirrhosis Patients.
The purpose of this study is to investigate the efficacy of umbilical cord mesenchymal stem cells (MSCs) infusion via hepatic artery in the treatment of liver cirrhosis.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | December 2012 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Aged 18~70 years. - Liver cirrhosis - written consent Exclusion Criteria: - The end-stage of liver cirrhosis. - Severe problems in other vital organs(e.g.the heart,renal or lungs). - Hepatocellular carcinoma or other malignancies - Pregnancy - sepsis - Presence of significant extrahepatic biliary disease (e.g. CBD stone, PSC, etc.) - Cardiac, renal or respiratory failure - Active thrombosis of the portal or hepatic veins |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Stem Cell Research Center of Medical School Hospital of Qingdao University | Qingdao | Shandong |
Lead Sponsor | Collaborator |
---|---|
Qingdao University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The result of liver function and liver histological improvement. | every 4 weeks | No | |
Secondary | The disappearance or reduction of abdominal dropsy | every 4 weeks | No | |
Secondary | The clinical symptom improve(including food appetite,debilitation,abdominal distension,edema of lower limbs ) | every 4 weeks | No |
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