A prospective, single center clinical study of umbilical cord mesenchymal stem cell transplantation for end-stage cirrhosis after hepatitis B

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100052843

Enrollment

Unknown

Registered

2021-11-06

Start date

2021-12-01

Completion date

Unknown

Last updated

2022-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

end-stage cirrhosis after hepatitis B

Interventions

UC-MSCs (umbilical cord mesenchymal stem cells) intervention group:UC-MSC portal vein infusion (week 0, week 24)

Eligibility

Sex/Gender

All

Age

20 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 20-60 years (male or female); 2. Diagnosed chronic decompensated hepatitis B cirrhosis with a course of more than 5 years; 3. Not suitable for liver transplantation, or no source of donor liver; 4. No serious bleeding tendency or active bleeding; 5. No hepatic encephalopathy; 6. After strict medical conservative treatment for more than 6 months, there was no relief of symptoms or significant improvement of quality of life score; 7. The subject voluntarily participate in this study and willing to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Family history of liver malignancy or patients with liver malignancy; 2. With hypersplenism which needs splenectomy; 3. Tumor history in other organ; 4. PT extension over 3 seconds; 5. Use of human serum albumin within 3 weeks prior to clinical enrollment; 6. Major upper gastrointestinal bleeding events of clinical significance occurred within 4 weeks prior to clinical registration; 7. Spontaneous peritonitis; 8. Active infection (viral or bacterial); 9. Pregnant or lactating women; 10. The investigator consider it inappropriate to participate in this study.

Design outcomes

Primary

Measure	Time frame
Overall survival;Child-Pugh Score;MELD(model for end-stage liver disease) Score;	—

Secondary

Measure	Time frame
FibroScan;Total bilirubin, albumin;Four items of liver fibrosis (HA, PIIINP, CIV, LN);Detection of immune function of peripheral blood cells (CD4+ and CD8+T cell, NK cell);Humoral immunoassay (IgA, IgG, IgM, IgE);Liver tumor markers (AFP, AFP-L3, CEA, CA19-9, CA15-3, PIVKA II);HBV-DNA;ECOG(Eastern Cooperative Oncology Group) Score;	—

Countries

China

Contacts

Public ContactHuang Xiaolun

Sichuan Provincial People's Hospital

huangxiaolun@med.uestc.edu.cn+86 28 87393752

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026