A Phase 1/2 interventional study of conventional plus MSC treatment and conventional plus placebo treatment in Liver Cirrhosis, sponsored by Beijing 302 Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-08-08.
Sponsored by Beijing 302 Hospital · Phase 1/2, Interventional, and Treatment
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. Particularly, autologous bone marrow-derived mesenchymal stem cell (BM-MSC) has been demonstrated to decrease MELD score and increase serum albumin in the patients with decompensated liver cirrhosis. Therefore, the investigators propose a hypothesis that umbilical cord-derived MSCs (UC-MSC) can also improve the disease conditions of LC patients, particularly reducing the decompensated conditions in these patients.
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.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's enrollment of 266 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Beijing 302 Hospital is the lead sponsor of 86 studies on the registry; 31 are open to participants now.
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Exclusion Criteria:
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
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 a dose of 0.5\*10E6 MSC/kg body for 8 weeks.
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
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Beijing 302 Hospital