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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Third Affiliated Hospital, Sun Yat-Sen University
Sponsor:
Information provided by (Responsible Party):
Zhiliang Gao, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01724398
First received: November 4, 2012
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Liver Failure
Other: Conventional plus UC-MSC treatment
Other: Conventional plus PE treatment
Other: Conventional plus UC-MSC and PE therapy
Other: Conventional treatment
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Third Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • Survival rate and time [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 120
Study Start Date: November 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Conventional treatment
Participants will receive conventional treatment and then be followed until the week 48 study visit.
Other: Conventional treatment
Received conventional treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
Experimental: Conventional plus UC-MSC treatment
Participants will receive conventional treatment plus a dose of UC-MSC and then be followed until the week 48 study visit.
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).
Experimental: Conventional plus PE treatment
Participants will receive conventional treatment plus plasma exchange and then be followed until the week 48 study visit.
Other: Conventional plus PE treatment
Received conventional treatment plus 2000 milliliter plasma exchange (every 3 days, 3 times).
Experimental: Conventional plus UC-MSC and PE therapy
Participants will receive conventional treatment plus umbilical cord mesenchymal stem cells transplantation combined with plasma exchange. Participants will then be followed until the week 48 study visit.
Other: 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724398

Contacts
Contact: Zhi-Liang Gao, Professor 86-20-85252373 zhilianggao@21cn.com
Contact: Hong-Liang He, Master 86-20-85253372 hehongliang0925@sina.com

Locations
China, Guangdong
Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Zhi-Liang Gao, Professor    86-20-85252373    zhilianggao@21cn.com   
Contact: Hong-Liang He, Master    86-20-85253372    hehongliang0925@sina.com   
Principal Investigator: Zhi-Liang Gao, Professor         
Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
Investigators
Principal Investigator: Zhi-Liang Gao, Doctor The Third Affliated Hospital of Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Zhiliang Gao, Professor, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01724398     History of Changes
Other Study ID Numbers: UCMSC-PE
Study First Received: November 4, 2012
Last Updated: February 27, 2013
Health Authority: China: Ministry of Health

Keywords provided by Third Affiliated Hospital, Sun Yat-Sen University:
mesenchymal stem cells
plasma exchange
liver failure
hepatitis B virus

Additional relevant MeSH terms:
Liver Failure
End Stage Liver Disease
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 31, 2014