Umbilical Cord Mesenchymal Stem Cell Transplantation for Decompensated Hepatitis B Cirrhosis

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asia Stem Cell Regenerative Pharmaceutical Co., Ltd.

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