Umbilical Cord Mesenchymal Stem Cell Transplantation for Decompensated Hepatitis B Cirrhosis

Last updated: October 31, 2021
Sponsor: Asia Stem Cell Regenerative Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hepatitis B

Scar Tissue

Hepatic Fibrosis

Treatment

N/A

Clinical Study ID

NCT05106972
SCT20181032
  • Ages 20-60
  • All Genders

Study 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

Inclusion Criteria:

  • Aged between 20 and 60 (male or female)
  • Diagnosed chronic decompensated hepatitis B cirrhosis with a course of more than 5years
  • 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 norelief of symptoms or significant improvement of quality of life score
  • Subjects voluntarily participate in this study and sign informed consent

Exclusion

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 andautoimmune hepatitis
  • Found liver malignant tumor or the family history of liver malignant tumor in thethird 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 weeksbefore clinical registration
  • Spontaneous peritonitis
  • Active infection (viral or bacterial)
  • Pregnant or lactating women
  • The researcher considers it inappropriate to participate in this study

Study Design

Total Participants: 30
Study Start date:
December 01, 2021
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Haikou People's Hospital

    Haikou,
    China

    Active - Recruiting

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