Status:
UNKNOWN
Safety and Efficacy Study of Co-transfering of Mesenchymal Stem Cell and Regulatory T Cells in Treating End-stage Liver Disease
Lead Sponsor:
Nanjing Medical University
Conditions:
Liver Cirrhosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Clinically diagnosed as decompensated liver cirrhosis.
- 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.
- 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.
- Need to intermittently supplement albumin and apply diuretic therapy.
- 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).
- 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.
- Unconditional acceptance of orthotopic liver transplantation.
- Aged from 18 to 65 years.
- Voluntarily signed informed consent form.
Exclusion
- A malignant tumor with liver or other organs or a history of previous cancer.
- Complications include gastrointestinal bleeding, spontaneous peritonitis, hepatic encephalopathy, hepatorenal syndrome, and Acute infection episodes.
- Patients with severe heart, lung, kidney or blood system diseases and failure status.
- Pregnant or lactating women.
- Allergic constitution.
- There is a history of alcohol abuse, drug abuse, and failure to effectively quit.
- Patients did not participate in other clinical trials within 4 weeks.
- Any condition, investigator believe that patients should not participate in this study.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03460795
Start Date
June 1 2020
End Date
September 1 2025
Last Update
March 4 2020
Active Locations (1)
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1
Nanjing Medical University
Nanjing, Jiangsu, China, 210029