Clinical trial NCT00956891: Therapeutic Effects of Liver Failure Patients Caused by Chronic Hepatitis B After Autologous MSCs Transplantation
Official title: Therapeutic Effects Including Short-term Changes And Long-term Outcomes of Liver Failure Patients Caused by Chronic Hepatitis B After Single Transplantation With Autologous Bone Marrow Mesenchymal Stem Cells.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Failure
Mesenchymal Stem Cells
Keywords: short-term effects
long-term follow-up
liver failure patients
autologous MSCs transplantation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2009-08-11
Enrollment: 158
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Liver failure patients with HBV infection

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Liver failure

Exclusion Criteria:

* HBV negative

Primary outcomes:
measure: Short-term therapeutic effects of transplantation.
timeFrame: 1 to 4 weeks after transplantation
Secondary outcomes:
measure: Long-term outcomes of transplantation.
timeFrame: 3 ~ 48 months years after transplantation
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Third Affiliated Hospital Of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Department of Infectious Diseases, 3rd Affiliated Hospital of Sun Yat-sen University, China
name: Zhi-liang Gao, Dr
role: STUDY_DIRECTOR
References: