Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis
|ClinicalTrials.gov Identifier: NCT03209986|
Recruitment Status : Unknown
Verified September 2018 by Han Ying, Xijing Hospital of Digestive Diseases.
Recruitment status was: Recruiting
First Posted : July 6, 2017
Last Update Posted : September 11, 2018
There has been great interest in recent years to take advantage of stem cells to treat liver cirrhosis. Mesenchymal stem cells (MSC) has been shown to be safe and effective for liver diseases in some studies. Randomization controlled studies are needed to confirm the long term effect of MSC treatment for liver cirrhosis. This study aimed to investigate the safety and efficacy of mesenchymal stem cells in hepatitis B and C related liver cirrhosis patients.
This study is an open-label multicenter randomized control study. Patients with with decompensated cirrhosis will be randomly assigned to receive MSC treatment plus standard medical care(treatment）or standard medical care (control). Three times of MSC infusion (1x10E6 cells/kg body weight) via peripheral vein will be given to the experimental group (once in 4 weeks). The primary outcome is absolute change in liver function indexes and and scores. Secondary outcomes are cirrhosis-related complications, symptoms, life quality, and survival.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cirrhosis||Procedure: mesenchymal stem cell transplantation via peripheral vein Other: mesenchymal stem cell||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Outcome assessors will be blind to the randomization results of the participants.|
|Official Title:||Randomized Control Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis Resulted From Viral Hepatitis|
|Actual Study Start Date :||November 8, 2017|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: MSC group
mesenchymal stem cell transplantation via peripheral vein: 1x10E6 MSCs/kg body weight administered via peripheral vein at week 0, 4, 8.
Procedure: mesenchymal stem cell transplantation via peripheral vein
1x10E6 MSCs/kg body weight will be administered via peripheral vein for 3 times at week 0, 4 and 8
Other: mesenchymal stem cell
mesenchymal stem cell infusion produced by Cell products of National Engineering Research Center(short for CPNERC), Tianjin, China
No Intervention: control
Standard medication for viral hepatitis and cirrhosis
- Efficacy: Change of liver functions as assessed by MELD score [ Time Frame: 1 year ]Change of liver functions as assessed by MELD score (MELD, Model for End-Stage Liver Disease Score: MELD = 3.78×ln[serum bilirubin (mg/dL)] + 11.2×ln[INR] + 9.57×ln[serum creatinine (mg/dL)] + 6.43)
- Safety: Adverse events as assessed according to CTCAE 4.03 [ Time Frame: 1 year ]Adverse events as assessed according to CTCAE 4.03
- Survival Benefit: Survival Rate at different time points [ Time Frame: 1 year, 2 year and 5 years ]survival rate at different time points
- Histological change of the liver: Histological scores assessed by liver biopsy [ Time Frame: 1 year, 2 year and 5 years ]histological scores assessed by liver biopsy at baseline and after treatment
- Clinical benefit: Incidences of cirrhosis-related complications such as GI bleeding, ascites, hepatorenal syndrome, hepatoencephalopathy [ Time Frame: 1, 2 and 5 years ]Incidences of cirrhosis-related complications such as GI bleeding, ascites, hepatorenal syndrome, hepatoencephalopathy
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): NCT03209986
|Contact: Changcun Guo, MDfirstname.lastname@example.org|
|Xijing Hospital of Digestive Disease, Xijing Hospital||Recruiting|
|Xi'an, Shaanxi, China, 710032|
|Contact: Ying Han, Ph.D 86-29-84771539 email@example.com|