Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02652351|
Recruitment Status : Unknown
Verified January 2016 by Shenzhen Hornetcorn Bio-technology Company, LTD.
Recruitment status was: Recruiting
First Posted : January 11, 2016
Last Update Posted : May 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hepatic Cirrhosis||Biological: Human umbilical cord mesenchymal stem cells||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||October 2016|
Experimental: hUC-MSC treatment
Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.
Biological: Human umbilical cord mesenchymal stem cells
A single dose of 2×107 hUC-MSC will be implanted to patients by intravenous infusion or Hepatic artery intervention, and repeated every week for four times.
Other Name: hUC-MSC
- Severity of adverse events [ Time Frame: 12 months ]According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)
- Hepatic function [ Time Frame: 1, 3 ,6 and 12 months ]Include AST, ALT, T-Bil and A/G.
- Liver fibrosis index [ Time Frame: 1, 3 ,6 and 12 months ]The level of Hyaluronidase,Laminin,Procollagen Ⅲ and Collagen Type IV in serum.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02652351
|Contact: Jin S Cao, lab master||+86 0734-53137955||CaoJS@hornetcon.com|
|The second Affiliated Hospital of University of Soth China||Recruiting|
|Hengyang, Hunan, China, 431224|
|Contact: Gang Chen, Professor 0734-8899939 ext 621 Chengang@126.com|
|Principal Investigator:||Gang Chen, Professor||The second Affiliated Hospital of University of Soth China|