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

NCT00956891 | Completed DMC

• 1 other identifier: SunYat-senU 5010 hepatitisB
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Failure; Mesenchymal Stem Cells

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Short-term therapeutic effects of transplantation.

  Biochemical indexes \[alanine aminotransferase (ALT), albumin (ALB), total bilirubin (TBIL), prothrombin time (PT) and Model for End-stage Liver Disease (MELD) \] were compared 1 to 4 weeks after transplantation.

  1 to 4 weeks after transplantation

Secondary Outcomes (1)

• Long-term outcomes of transplantation.

  3 ~ 48 months years after transplantation

Study Arms (2)

group A

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

group B

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

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Liver failure patients with HBV infection

You may qualify if:

• Liver failure

You may not qualify if:

• HBV negative

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The Third Affiliated Hospital Of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

MeSH Terms

Conditions

Liver Failure

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Zhi-liang Gao, Dr

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 10, 2009
• First Posted: August 11, 2009
• Study Start: May 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2010
• Last Updated: December 7, 2010

Record last verified: 2009-08

Locations

CN (1)