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

• Sponsor: Air Force Military Medical University, China (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01724697
• 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cirrhosis; End Stage Liver Disease	Other: BMSC transplantation; Other: conventional treatment & antivrial 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 Bone Marrow 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 treatment conventional treatment & antivrial treatment.	Other: conventional treatment & antivrial treatment; Participants will recieve conventional treatment and antivrial treatment.
Experimental: BMSC transplantation conventional treatment & antiviral treatment & autologous bone marrow stem cell transplantation via hepatic artery	Other: BMSC transplantation; Patients randomized to the intervention arm will be collected for bone marrow stem cells and then infused with these cells 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, 9 months and 1year after treatment]

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

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

4. child score [1week, 4weeks, 3months, 6months, 9 months 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.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

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: NCT01724697
• Other Study ID Numbers: 20120912-1
• First Posted: Nov 12, 2012
• Last Update Posted: Nov 12, 2012
• Last Verified: Nov 1, 2012

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

Study Results

No Results Posted as of Nov 12, 2012