Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal Stem Cells for Treatment of HBV-related Liver Cirrhosis
|ClinicalTrials.gov Identifier: NCT01728727|
Recruitment Status : Unknown
Verified November 2012 by Han Ying, Fourth Military Medical University.
Recruitment status was: Recruiting
First Posted : November 20, 2012
Last Update Posted : November 20, 2012
HBV related Liver disease is a common medical problem in China. An estimated 7.18% of the Chinese (about 93 million) is infected with hepatitis B, and most of the HBV- related hepatitis can developed into liver cirrhosis.
Liver transplantation is the only available life saving treatment for patients with end stage liver disease. However, lack of donors, surgical complications, rejection, and high cost are serious problems.
Mesenchymal stem cells (MSCs) possess plasticity and have the potential to differentiate into hepatocyte; Thus, MSCs hold great hope for therapeutic applications. Human umbilical cord-derived MSCs (hUC-MSCs) exhibit a more beneficial immunogenic profile and greater overall immunosuppressive potential than aged bone marrow-derived MSCs. Like MSCs derived from bone marrow, hUC-MSCs can also be used to treat rat liver fibrosis and improve glucose homeostasis in rats with liver cirrhosis. In this study, the patients with HBV-related liver cirrhosis will undergo administration of hUC-MSCs via hepatic artery to evaluate the safety and efficacy of hUC-MSC treatment for these patients.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cirrhosis End Stage Liver Disease||Other: UC-MSC transplantation Other: conventional treatment||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal Stem Cells for Treatment of HBV-related Liver Cirrhosis|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||September 2015|
Active Comparator: conventional
conventional treatment & antiviral treatment
Other: conventional treatment
Participants will receive conventional treatment and antiviral treatment.
Experimental: UC-MSC transplantation
Participants will receive umbilical cord derived mesenchymal stem cell treatment at day 1 and conventional treatment and antiviral treatment through the one year study visit. Participants will then be followed until one years study visit
Other: UC-MSC transplantation
After enrolled, Participant will receive umbilical cord MSC transplantation of 1*10E6 cells/kg via hepatic artery. Participant will then be followed until 1 years study visit
- one year survival rate [ Time Frame: one year after treatment ]
- MELD score [ Time Frame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment ]
- Child Pugh Score [ Time Frame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment ]
- alpha fetoprotein [ Time Frame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment ]
- renal function [ Time Frame: 1week, 4weeks,3months, 6months, 9months and 1year after treatment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01728727
|Contact: ying firstname.lastname@example.org|
|Contact: yongquan email@example.com|
|Xijing Hospital of Digestive Disease||Recruiting|
|Xi'an, Shaanxi, China, 710032|
|Contact: Ying Han 86-29-84771539 firstname.lastname@example.org|
|Contact: Yongquan Shi 86-29-84771515 email@example.com|
|Study Chair:||Daiming Fan||Fourth Military Medical University|