Clinical trial NCT05106972: Umbilical Cord Mesenchymal Stem Cell Transplantation for Decompensated Hepatitis B Cirrhosis
Official title: A Single Center, Prospective Study of Umbilical Cord Mesenchymal Stem Cell Transplantation for Decompensated Hepatitis B Cirrhosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Cirrhosis
Lead sponsor: Asia Stem Cell Regenerative Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-11-04
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the safety and clinical efficacy of umbilical cord mesenchymal stem cell transplantation for decompensated hepatitis B cirrhosis.


Eligibility criteria: Inclusion Criteria:

* Aged between 20 and 60 (male or female)
* Diagnosed chronic decompensated hepatitis B cirrhosis with a course of more than 5 years
* Not suitable for liver transplantation or there is no donor liver source
* No serious bleeding tendency or active bleeding
* No hepatic encephalopathy
* After strict medical conservative treatment for more than 6 months, there was no relief of symptoms or significant improvement of quality of life score
* Subjects voluntarily participate in this study and sign informed consent

Exclusion Criteria:

* Be less than 20 years old or more than 60 years old
* Cirrhosis caused by other causes such as alcoholic hepatitis, hepatitis C virus and autoimmune hepatitis
* Found liver malignant tumor or the family history of liver malignant tumor in the third generation of their direct relatives
* Patients with hypersplenism who need splenectomy
* History of tumors in other organs
* PT prolongation is greater than 3 seconds
* Use of human serum albumin within 3 weeks prior to clinical registration
* Clinically significant upper gastrointestinal bleeding events occurred within 4 weeks before clinical registration
* Spontaneous peritonitis
* Active infection (viral or bacterial)
* Pregnant or lactating women
* The researcher considers it inappropriate to participate in this study

Primary outcomes:
measure: Number of Participants with abnormal Total bilirubin
timeFrame: Changes from baseline to 72 weeks
measure: Number of Participants with abnormal albumin
timeFrame: Changes from baseline to 72 weeks
measure: Ishak Inflammation Rating System
timeFrame: Changes from baseline to 72 weeks
measure: Ishak Fibrosis Score
timeFrame: Changes from baseline to 72 weeks
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Changes from baseline to 72 weeks
measure: HBV-DNA
timeFrame: Changes from baseline to 72 weeks
measure: incidence of liver cancer
timeFrame: Changes from baseline to 72 weeks
measure: Number of Participants with abnormal immunoglobulin
timeFrame: Changes from baseline to 72 weeks
measure: portal vein flow rate
timeFrame: Changes from baseline to 72 weeks
measure: portal vein width
timeFrame: Changes from baseline to 72 weeks
measure: abdominal volume
timeFrame: Changes from baseline to 72 weeks
measure: Number of Participants with abnormal coagulation function
timeFrame: Changes from baseline to 72 weeks
Other outcomes:
Locations:
city: Haikou
country: China
facility: Haikou People's Hospital
Study officials:
References: