Safety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hepatic Cirrhosis
- Sponsor
- Shenzhen Hornetcorn Bio-technology Company, LTD
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Severity of adverse events
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Hepatic Cirrhosis.
Detailed Description
Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into mature cells typical of several tissues, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of Hepatic Cirrhosis. To investigate the effects of hUC-MSC treatment for Hepatic Cirrhosis, 20 patients with Hepatic Cirrhosis will be enrolled and receive 4 times of hUC-MSC transplantation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patient who have signed the informed consent document;
- •Clinical, radiological, or biochemical evidence of liver cirrhosis.
Exclusion Criteria
- •Pregnant women or lactating mothers;
- •Patients who have received any anti-inflammatory drugs including herb-drug within 14 days;
- •Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment;
- •Patients with positive human immunodeficiency (HIV) at screening indicative of current of pass infection;
- •Abnormal blood coagulation, combine other tumor or special condition;
- •Patients who had participated in other clinical trials within three months prior to this study.
Outcomes
Primary Outcomes
Severity of adverse events
Time Frame: 12 months
According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)
Secondary Outcomes
- Hepatic function(1, 3 ,6 and 12 months)
- Liver fibrosis index(1, 3 ,6 and 12 months)