Therapeutic Effects of Liver Failure Patients Caused by Chronic Hepatitis B After Autologous MSCs Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

158 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-05-31

Study Completion Date

2010-07-31

Brief Summary

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The study aimed to investigate the short-term efficacy and long-term prognosis of liver failure patients caused by hepatitis B after single transplantation with autologous marrow mesenchymal stem cells (MMSCs). Liver failure inpatients caused by hepatitis B were recruited and received the same medical treatments, among whom some patients underwent single transplantation with autologous MMSCs and other patients with matched age, gender and biochemical indexes \[alanine aminotransferase (ALT), albumin (ALB), total bilirubin (TBIL), prothrombin time (PT) and Model for End-stage Liver Disease (MELD) \] were in control group. A total of 120 ml bone marrow were obtained from patients, diluted and separated. Then MMSCs suspension were slowly transfused into the liver through the proper hepatic artery by interventional procedures. The levels of ALB, TBIL, PT and MELD score of patients in translation group were compared with those in control group. In 3 \~ 48 months of follow-up, differences in long-term outcomes such as incidence of HCC (hepatocellular carcinoma) and mortality between two groups were compared.

Detailed Description

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A total of 527 patients with chronic hepatitis B induced liver failure were recruited from May 2005 to June 2009 from our department. The diagnoses of chronic hepatitis B and liver failure were based on previously described criteria. All patients received the same medical treatments (reducibility glutathione, glycyrrhizin, ademetionine, polyene phosphatidylcholine, alprostadil, and human serum albumin). Informed consent was obtained before study. Among these patients, 53 received transplantation with autologous MMSCs. The day of surgery served as the first day of observation. And 105 patients with matched age, gender and some biochemical indexes (ALT, ALB, TBIL, PT and MELD ) were served as controls.

Conditions

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Liver Failure Mesenchymal Stem Cells

Keywords

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short-term effects long-term follow-up liver failure patients autologous MSCs transplantation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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group A

autologous MSCs transplantation were performed plus medical treatments (reducibility glutathione, glycyrrhizin, ademetionine, polyene phosphatidylcholine, alprostadil, and human serum albumin)

No interventions assigned to this group

group B

only medical treatments (reducibility glutathione, glycyrrhizin, ademetionine, polyene phosphatidylcholine, alprostadil, and human serum albumin) were performed without autologous MSCs transplantation.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Liver failure

Exclusion Criteria

* HBV negative

Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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The Third Affliated Hospital of Sun Yat-sen University

Principal Investigators

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Zhi-liang Gao, Dr

Role: STUDY_DIRECTOR

Department of Infectious Diseases, 3rd Affiliated Hospital of Sun Yat-sen University, China

Locations

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The Third Affiliated Hospital Of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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SunYat-senU 5010 hepatitisB

Identifier Type: -

Identifier Source: org_study_id