Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis

Liver Cirrhosis Clinical Trial

Official title:

Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01728688
• Other study ID #: 20120912-2
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: October 31, 2012
• Last updated: November 13, 2012
• Start date: September 2012
• Est. completion date: September 2015

Study information

• Verified date: November 2012
• Source: Fourth Military Medical University
• Contact: Ying Han
• Phone: 86-29-84771539
• Email: hanying[@]fmmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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.

In preclinical studies the investigators have demonstrated that G-CSF mobilized PBSC from patients with HBV related liver cirrhosis could differentiate into functional hepatocyte and autologous PBSC transplantation can significantly improve liver synthetic function. But further studied was needed to confirm the safety and efficacy of PBSC transplantation. In this study, a prospective, randomized, parallel clinical study was designed. The patients with HBV-related liver cirrhosis will undergo administration of human autologous PBSCs via hepatic artery to evaluate the safety and efficacy of human autologous PBSCs treatment for these patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: September 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 -

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Liver Disease
• Liver Cirrhosis
• Liver Diseases

Intervention

Other:
• PBSC transplantation
PBSCs were mobilized with recombinant human G-CSF at 5-10ug/kg/d for three days. then PBSCs were collected by means of apheresis. The collected PBSCs were infused into participant via hepatic artery
• conventional treatment
Participants will receive conventional treatment and antiviral treatment.

Locations

Country	Name	City	State
China	Xijing Hospital of Digestive Disease	Xi'an	Shaanxi

Sponsors (5)

Lead Sponsor	Collaborator
Fourth Military Medical University	Chinese Academy of Medical Sciences, Eastern Hepatobiliary Surgery Hospital, Fudan University, The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	one-year survival rate		one year after treatment	Yes
Secondary	MELD score		1week, 4weeks,3months, 6months, 9months and 1year after treatment	Yes
Secondary	Child Pugh Score		1week, 4weeks,3months, 6months, 9months and 1year after treatment	Yes
Secondary	alpha fetoprotein		1week, 4weeks,3months, 6months, 9months and 1year after treatment	Yes
Secondary	renal function		1week, 4weeks,3months, 6months, 9months and 1year after treatment	Yes