Umbilical Cord Mesenchymal Stem Cells for Patients With Liver Cirrhosis
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|ClinicalTrials.gov Identifier: NCT01220492|
Recruitment Status : Completed
First Posted : October 14, 2010
Last Update Posted : August 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Liver Cirrhosis||Drug: conventional plus MSC treatment Drug: conventional plus placebo treatment||Phase 1 Phase 2|
Liver cirrhosis (LC) represents a late stage of progressive hepatic fibrosis characterized by distortion of the hepatic architecture and formation of regenerative nodules. The liver transplantation is one of the only effective therapies available to such patients. However, lack of donors, surgical complications, rejection, and high cost are it's serious problems.
The potential for stem cells to differentiate into hepatocytes cells was recently confirmed. In particular, bone marrow-derived mesenchymal stem cell (BM-MSC) transplantation has been applicated in the clinic for treat several human diseases such as GVHD, cardiac injury and brain injury, and displayed good tolerance and efficiency. BM-MSC has also been used to treat human liver diseases such as liver failure and liver cirrhosis. In a phase 1 study, autologous BM-MSC transplantation has potential to decrease MELD score and increase serum albumin in the patients with decompensated liver cirrhosis.
The purpose of this study is to learn whether and how umbilical cord-derived MSCs (UC-MSC) can improve the longer term survival in patients with liver cirrhosis. This study will also look at how well BM-MSC is tolerated and its safety in LC patients.
Participants in the study will be randomly assigned to one of two treatment arms:
Arm A: Participants will receive conserved treatment plus three times UC-MSC treatment at 4-week intervals.
Arm B: Participants will receive conserved treatment plus three times saline infusions at 4-week intervals.
UC-MSC will be prepared according to standard procedures and is collected in plastic bags containing anti coagulant. MSCs are infused intravenously. After cell therapy, patients are followed up for 75 months. The evaluation of some clinical parameters such as the level of serum alanine aminotransferase (ALT), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), the rountin blood test are detected at week 12, 24, 48 timepoints. Clinical symptoms as well as complication were also observed simultaneously.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||266 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1/2 Study of UC-MSC Treatment for the Evaluation the Efficacy and Safety in Patients With Liver Cirrhosis|
|Actual Study Start Date :||May 2009|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
Experimental: conventional plus MSC treatment
participants will receive conventional treatment plus a dose of MSC from day 0 through the week 8 study visit. Participants will then be followed until the 75 months study visit.
Drug: conventional plus MSC treatment
received conventional treatment and taken i.v., once per 4 week, at a dose of 0.5*10E6 MSC/kg body for 8 weeks.
Experimental: conventional plus placebo treatment
participants will receive conventional plus placebo treatment from day 0 through the week 8 study visit. Participants will then be followed until the 75 months study visit.
Drug: conventional plus placebo treatment
received conventional treatment and taken i.v., once per 4 week, at 50 ml saline for 8 weeks.
- survival time [ Time Frame: 75 months ]
- incidence of HCC events [ Time Frame: 75 months ]
- The levels of serum albumin [ Time Frame: 48 weeks ]
- The levels of serum total bilirubin [ Time Frame: 48 weeks ]
- The levels of serum prothrombin activity [ Time Frame: 48 weeks ]
- the levels of serum cholinesterase [ Time Frame: 48 weeks ]
- complications [ Time Frame: 48 weeks ]
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): NCT01220492
|Beijing 302 Hospital|
|Beijing, Beijing, China, 100039|
|Principal Investigator:||Fu-Sheng Wang, Professor||Beijing 302 Hospital|