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

• Sponsor: Air Force Military Medical University, China (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01728688
• Collaborator: The Second Affiliated Hospital of Chongqing Medical University (Other), Eastern Hepatobiliary Surgery Hospital (Other), Chinese Academy of Medical Sciences (Other), Fudan University (Other)
• Enrollment: 240
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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.

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cirrhosis; End Stage Liver Disease	Other: PBSC transplantation; Other: conventional treatment	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis
• Study Start Date: Sep 1, 2012
• Anticipated Primary Completion Date: Sep 1, 2014
• Anticipated Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional conventional treatment & antiviral treatment	Other: conventional treatment; Participants will receive conventional treatment and antiviral treatment.
Experimental: conventional & PBSC transplantation After three days G-CSF mobilization, Patients randomized to the intervention arm will receive autologous PBSCs transplantation at day1, and receive conventional treatment and antiviral treatment through the one year study visit and followed until one years study visit.	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

Outcome Measures

Primary Outcome Measures

1. one-year survival rate [one year after treatment]

Secondary Outcome Measures

1. MELD score [1week, 4weeks,3months, 6months, 9months and 1year after treatment]

2. Child Pugh Score [1week, 4weeks,3months, 6months, 9months and 1year after treatment]

3. alpha fetoprotein [1week, 4weeks,3months, 6months, 9months and 1year after treatment]

4. renal function [1week, 4weeks,3months, 6months, 9months and 1year after treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xijing Hospital of Digestive Disease	Xi'an	Shaanxi	China	710032

Sponsors and Collaborators

• Air Force Military Medical University, China
• The Second Affiliated Hospital of Chongqing Medical University
• Eastern Hepatobiliary Surgery Hospital
• Chinese Academy of Medical Sciences
• Fudan University

Investigators

• Study Chair: Daiming Fan, Air Force Military Medical University, China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Han Ying, professor, Air Force Military Medical University, China
• ClinicalTrials.gov Identifier: NCT01728688
• Other Study ID Numbers: 20120912-2
• First Posted: Nov 20, 2012
• Last Update Posted: Nov 20, 2012
• Last Verified: Nov 1, 2012

• Keywords provided by Han Ying, professor, Air Force Military Medical University, China: liver cirrhosis; stem cell; peripheral blood; autologous; HBV; end stage liver disease
• Additional relevant MeSH terms: Liver Cirrhosis; Liver Diseases; End Stage Liver Disease; Fibrosis

Study Results

No Results Posted as of Nov 20, 2012