Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal Stem Cells for Treatment of HBV-related Liver Cirrhosis

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01728727

Enrollment

240

Registered

2012-11-20

Start date

2012-09-30

Completion date

2015-09-30

Last updated

2012-11-20

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

Conditions

End Stage Liver Disease, Liver Cirrhosis

Keywords

liver cirrhosis, end stage liver disease, umbilical cord, mesenchymal stem cells, HBV

Brief summary

HBV related Liver disease is a common medical problem in China. An estimated 7.18% of the Chinese (about 93 million) is infected with hepatitis B, and most of the HBV- related hepatitis can developed into liver cirrhosis. Liver transplantation is the only available life saving treatment for patients with end stage liver disease. However, lack of donors, surgical complications, rejection, and high cost are serious problems. Mesenchymal stem cells (MSCs) possess plasticity and have the potential to differentiate into hepatocyte; Thus, MSCs hold great hope for therapeutic applications. Human umbilical cord-derived MSCs (hUC-MSCs) exhibit a more beneficial immunogenic profile and greater overall immunosuppressive potential than aged bone marrow-derived MSCs. Like MSCs derived from bone marrow, hUC-MSCs can also be used to treat rat liver fibrosis and improve glucose homeostasis in rats with liver cirrhosis. In this study, the patients with HBV-related liver cirrhosis will undergo administration of hUC-MSCs via hepatic artery to evaluate the safety and efficacy of hUC-MSC treatment for these patients.

Interventions

OTHERUC-MSC transplantation

After enrolled, Participant will receive umbilical cord MSC transplantation of 1\*10E6 cells/kg via hepatic artery. Participant will then be followed until 1 years study visit

OTHERconventional treatment

Participants will receive conventional treatment and antiviral treatment.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Aged 18-65 years 2. HBV-related liver cirrhosis 3. Child-Pugh score 9-15 4. Written consent -

Exclusion criteria

1. Hepatocellular carcinoma or other malignancies 2. Severe problems in other vital organs(e.g.the heart,renal or lungs) 3. Pregnant or lactating women 4. Severe bacteria infection 5. Anticipated with difficulty of follow-up observation 6. Other candidates who are judged to be not applicable to this study by doctors

Design outcomes

Primary

Measure	Time frame
one year survival rate	one year after treatment

Secondary

Measure	Time frame
MELD score	1week, 4weeks,3months, 6months, 9months and 1year after treatment
Child Pugh Score	1week, 4weeks,3months, 6months, 9months and 1year after treatment
alpha fetoprotein	1week, 4weeks,3months, 6months, 9months and 1year after treatment
renal function	1week, 4weeks,3months, 6months, 9months and 1year after treatment

Countries

China

Contacts

Primary Contactying han

hanying@fmmu.edu.cn86-29-84771539

Backup Contactyongquan shi

shiyquan@fmmu.edu.cn86-29-84771515

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026