Safety and Efficacy Study of Co-transfering of Mesenchymal Stem Cell and Regulatory T Cells in Treating End-stage Liver Disease
Safety and Efficacy Study of Co-transfering of Mesenchymal Stem Cell and Regulatory T Cells in Treating End-stage Liver Disease
Cirrhosis of the liver is a common clinical chronic progressive liver disease, which is a
 diffuse liver lesion caused by one or more causes over a long period of time or repeatedly.
 Nodules, abnormal spherical areas of cells, form as dying liver cells are replaced by
 regenerating cells. This regeneration of cells causes the liver to become hard. The potential
 for stem cells to differentiate into hepatocytes cells was recently confirmed. In particular,
 mesenchymal stem cell (MSC) transplantation has been applicated in the clinic for treat
 several human diseases such as liver injury and liver fibrosis displayed good tolerance and
 efficiency. Besides, regulatory T cells(Tregs) had been proved as an immune regualtory T cell
 subsets, which could reduce immune cell activation and reduce liver injury severity. The
 purpose of this study is to learn whether and how MSCs and Tregs can improve the disease
 conditions in patients with decompensated cirrhosis.
Cirrhosis of the liver is a common clinical chronic progressive liver disease, which is a
 diffuse liver lesion caused by one or more causes over a long period of time or repeatedly.
 Nodules, abnormal spherical areas of cells, form as dying liver cells are replaced by
 regenerating cells. This regeneration of cells causes the liver to become hard. Decompensated
 liver cirrhosis is mainly manifested by liver function damage and portal hypertension, with
 multiple system involvement. Complications such as upper gastrointestinal hemorrhage, hepatic
 encephalopathy, secondary infection, hypersplenism, ascites, and carcinogenesis often occur
 in the late stage. The potential for stem cells to differentiate into hepatocytes cells was
 recently confirmed. In particular, mesenchymal stem cell (MSC) and Tregs transplantation had
 been applicated in the clinic for treat several human diseases such as liver injury and liver
 fibrosis displayed good tolerance and efficiency. The purpose of this study is to learn
 whether and how MSCs and Tregs can improve the disease conditions in patients with
 decompensated cirrhosis.
Inclusion Criteria:

 1. Clinically diagnosed as decompensated liver cirrhosis.

 2. Hepatitis B/C Liver Cirrhosis After Viral Treatment, HBV/HCV Viral Loads Below
 Detection Level over six mouths, and the liver function remained below Child-pugh A
 grade or MELD score >10.

 3. Other causes of cirrhosis, liver function compensatory incomplete. In the past year,
 despite active medical treatment taken, the condition has continued to increase, at
 least because of cirrhosis complications such as ascites, spontaneous peritonitis,
 gastrointestinal bleeding, and hepatic encephalopathy in hospital over one time.

 4. Need to intermittently supplement albumin and apply diuretic therapy.

 5. Albumin <35 g/L, total bilirubin <170 umol/L, prothrombin activity> 30%; (Prothrombin
 time <20 s, moderate or lower mass ascites, spontaneous peritonitis and hepatic
 encephalopathy (grade II or lower), Child-pugh score> 5 points).

 6. There was no history of gastrointestinal hemorrhage within the last month and
 population with no high-risk portal hypertension and gastrointestinal bleeding was
 evaluated recently.

 7. Unconditional acceptance of orthotopic liver transplantation.

 8. Aged from 18 to 65 years.

 9. Voluntarily signed informed consent form.

 Exclusion Criteria:

 1. A malignant tumor with liver or other organs or a history of previous cancer.

 2. Complications include gastrointestinal bleeding, spontaneous peritonitis, hepatic
 encephalopathy, hepatorenal syndrome, and Acute infection episodes.

 3. Patients with severe heart, lung, kidney or blood system diseases and failure status.

 4. Pregnant or lactating women.

 5. Allergic constitution.

 6. There is a history of alcohol abuse, drug abuse, and failure to effectively quit.

 7. Patients did not participate in other clinical trials within 4 weeks.

 8. Any condition, investigator believe that patients should not participate in this
 study.