Clinical trial NCT01724697: Safety and Efficacy of Human Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis
Official title: Safety and Efficacy of Human Autologous Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Liver Cirrhosis
End Stage Liver Disease
Keywords: liver cirrhosis
end stage liver disease
HBV
autologous
stem cell
bone morrow
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
Collaborators: name: The Second Affiliated Hospital of Chongqing Medical University
name: Eastern Hepatobiliary Surgery Hospital
name: Chinese Academy of Medical Sciences
name: Fudan University
First posted: 2012-11-12
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: one year survival rate
timeFrame: one year after treatment
Secondary outcomes:
measure: MELD score
timeFrame: 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment
measure: AFP
timeFrame: 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment
measure: renal function
timeFrame: 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment
measure: child score
timeFrame: 1week, 4weeks, 3months, 6months, 9 months and 1year after treatment
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Disease
state: Shaanxi
Study officials:
affiliation: Air Force Military Medical University, China
name: Daiming Fan
role: STUDY_CHAIR
References: