Safety and Efficacy of Human Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis

Safety and Efficacy of Human Autologous Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01724697

Enrollment

240

Registered

2012-11-12

Start date

2012-09-30

Completion date

2015-09-30

Last updated

2012-11-12

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, HBV, autologous, stem cell, bone morrow

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. stem cells(SCs) possess plasticity and have the potential to differentiate into hepatocyte; Thus, SCs hold great hope for therapeutic applications. Adult bone marrow is the most common source of SCs for clinical applications.Previous study showed that bone marrow derived stem cells (BMSCs) replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration. In this study, the patients with HBV-related liver cirrhosis will undergo administration of human autologous BMSCs via hepatic artery to evaluate the safty and efficacy of human autologous BMSCs treatment for these patients.

Interventions

OTHERBMSC transplantation

Patients randomized to the intervention arm will be collected for bone marrow stem cells and then infused with these cells via hepatic artery.

OTHERconventional treatment & antivrial treatment

Participants will recieve conventional treatment and antivrial 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.theheart,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, 9 months and 1year after treatment
AFP	1week, 4weeks, 3months, 6months, 9 months and 1year after treatment
renal function	1week, 4weeks, 3months, 6months, 9 months and 1year after treatment
child score	1week, 4weeks, 3months, 6months, 9 months and 1year after treatment

Countries

China

Outcome results

None listed

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