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Umbilical Cord Mesenchymal Stem Cell Transplantation for Decompensated Hepatitis B Cirrhosis

A

Asia Stem Cell Regenerative Pharmaceutical

Status

Enrolling

Conditions

Liver Cirrhosis

Treatments

Drug: UC-MSC infusion

Study type

Interventional

Funder types

Industry

Identifiers

NCT05106972
SCT20181032

Details and patient eligibility

About

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

Enrollment

30 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

UC-MSC infusion
Experimental group
Description:
UC-MSC infusion by intravenus, 1\*10\^8 cells/dose, 2 doses (apart from 24weeks)
Treatment:
Drug: UC-MSC infusion

Trial contacts and locations

1

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Central trial contact

Xiaoxi Huang, PHD

Data sourced from clinicaltrials.gov

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