Umbilical Cord Mesenchymal Stem Cells Transplantation Combined With Plasma Exchange for Patients With Liver Failure

Liver Failure Clinical Trial

Official title:

Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells Transplantation Combined With Plasma Exchange for Patients With Acute-on-Chronic Liver Failure Caused by Hepatitis B Virus (HBV)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01724398
• Other study ID #: UCMSC-PE
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: November 4, 2012
• Last updated: February 27, 2013
• Start date: November 2012
• Est. completion date: March 2015

Study information

• Verified date: February 2013
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Zhi-Liang Gao, Professor
• Phone: 86-20-85252373
• Email: zhilianggao[@]21cn.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Liver failure (LF) is a dramatic clinical syndrome with massive necrosis of liver cells. Although liver transplantation provides an option to cure patients suffering with LF, lack of donors, postoperative complications, especially rejection, and high cost limit its application. Previous study showed that bone marrow derived mesenchymal stem cells (BM-MSCs) the novel and promising therapeutic strategy, BM-MSCs can replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration. Plasma exchange (PE) can improve internal environment by removing endotoxin, it helps the liver regeneration and functional recovery and make UC-MSC differentiation into hepatocyte like cells, and exert immunomodulatory function. In this study, safety and efficacy of human umbilical cord mesenchymal stem cells (UC-MSCs) transplantation combined with plasma exchange (PE) for patients with liver failure caused by hepatitis B Virus will be evaluated.

Description:

To investigate safety and efficacy of human umbilical cord mesenchymal stem cells (UC-MSCs) transplantation combined with plasma exchange (PE) for patients with liver failure caused by hepatitis B virus.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

• Written informed consent

• Acute-on-Chronic liver failure caused by hepatitis B virus

• Model for End-Stage Liver Disease (MELD) <30

Exclusion Criteria:

• Liver failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on

• History of severe hepatic encephalopathy or variceal bleeding during the last two months before enrollment

• Severe problems in other vital organs(e.g. the heart, renal or lungs)

• Severe bacteria infection

• Tumor on ultrasonography, CT or MRI examination

• Pregnant or lactating women

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Failure

Intervention

Other:
• Conventional plus UC-MSC treatment
Received conventional treatment and umbilical cord mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×105/Kg, once a week, 4 times).
• Conventional plus PE treatment
Received conventional treatment plus 2000 milliliter plasma exchange (every 3 days, 3 times).
• Conventional plus UC-MSC and PE therapy
Received conventional treatment plus 2000 milliliter plasma exchange (every 3 days, 3 times). Meantime taken i.v umbilical cord mesenchymal stem cells transplantation slowly for 30minutes (1×105/Kg, once a week, 4 times), the first two times is taken after plasma exchange.
• Conventional treatment
Received conventional treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.

Locations

Country	Name	City	State
China	Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate and time		48 weeks	No
Secondary	Improve biochemical indexes [alanine aminotransferase (ALT), albumin (ALB), total bilirubin (TBIL), prothrombin time (PT), INR and so on]		24 weeks after treatment	No
Secondary	The clinical symptom improvement [including appetite, debilitation, abdominal distension, edema of lower limbs, et al]		24 weeks after treatment	No
Secondary	Liver function evaluation using Child-Pugh score and MELD score		24 weeks after treatment	No
Secondary	Immune function improvement [including Th1/Th2]		24 weeks after treatment	No
Secondary	The occurrence of complications [including body temperature, tetter and allergy]		Between 0 to 8 hours after UC-MSCs transfusion	Yes
Secondary	Incidence of hepatocellular carcinoma		48 weeks after treatment	Yes