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Safety and Efficacy of Diverse Mesenchymal Stem Cells Transplantation for Liver Failure

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ClinicalTrials.gov Identifier: NCT01844063
Recruitment Status : Recruiting
First Posted : May 1, 2013
Last Update Posted : July 8, 2013
Sponsor:
Information provided by (Responsible Party):
Qi Zhang, MD, Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary:
HBV-related liver failure (HBV-LF), a dramatic clinical syndrome, is characterized with massive necrosis of liver cells. Liver transplantation might be the most effective therapy for HBV-LF. However, there are a lot of problems such as lack of donors, surgical complications, transplant rejection, and high cost, which could limit the application of liver transplantation. It is demonstrated that mesenchymal stem cells could directionally differentiate into hepatocytes and cholangiocytes in injured liver, as well as reduce inflammation of the liver by immune regulation. In this study, we assess the safety and efficacy of human bone marrow and umbilical cord mesenchymal stem cells transplantation for patients with HBV-LF.

Condition or disease Intervention/treatment Phase
Liver Failure Genetic: Conventional plus BM-MSC treatment Genetic: Conventional plus UC-MSC treatment Drug: Conventional treatment Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Comparison of Safety and Efficacy of Allogeneic Umbilical-Cord and Bone Marrow-derived Mesenchymal Stem Cells Transplantation for HBV-related Liver Failure
Study Start Date : July 2013
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2019

Arm Intervention/treatment
Experimental: Conventional treatment
Participants will receive conventional treatment and then be followed until the week 72 study visit.
Drug: Conventional treatment

Received conventional treatment including:

A.antiviral drugs(Entecavir,Lamivudine,Adefovir dipivoxil,et al); B.Hepatoprotective drugs(Ademetionine1,4-butanethiosulfonate for Injection, Reduced Glutathione for Injection,Polyene Phosphatidylcholine, et al); C.Plasma.

Other Names:
  • Antiviral drugs
  • Hepatoprotective drugs
  • Plasma

Experimental: Conventional plus BM-MSC treatment
Participants will receive conventional treatment plus a dose of BM-MSC(each subgroups with a different dose ) and then be followed until the week 72 study visit.
Genetic: Conventional plus BM-MSC treatment
Received conventional treatment and bone marrow mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×10e5/Kg,1×10e6/Kg,or 1×10e7/Kg, once a week, 8 times).

Experimental: Conventional plus UC-MSC treatment
Participants will receive conventional treatment plus a dose of UC-MSC(each subgroups with a different dose ) and then be followed until the week 72 study visit.
Genetic: Conventional plus UC-MSC treatment
Received conventional treatment and bone marrow mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×10e5/Kg,1×10e6/Kg,or 1×10e7/Kg, once a week, 8 times)




Primary Outcome Measures :
  1. survival rate [ Time Frame: 72 weeks ]
    The survival rate and time


Secondary Outcome Measures :
  1. Liver function [ Time Frame: 72 weeks after treatment ]
    The levels of serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST),Cholinesterase (CHE) ,Total Bilirubin(TB),Direct Bilirubin(DB), Serum Albumin (ALB)

  2. Marker of liver cancer [ Time Frame: 72 weeks after treatment ]
    The level of alpha-fetoprotein (AFP)

  3. The degree of hepatic necrosis [ Time Frame: 2 years after treatment ]
    The levels of Prothrombin Activity (PA) and Prothrombin Time (PT)

  4. The improvement of symptoms [ Time Frame: 72 weeks after treatment ]
    The improvement of clinical symptoms [including appetite, debilitation, abdominal distension, edema of lower limbs, et al

  5. The score for Model for End-Stage Liver Disease [ Time Frame: 72 weeks after treatment ]
  6. The improvement of immune function [ Time Frame: 72 weeks after treatment ]
    cluster of differentiation 4 (CD4+)T/ cluster of differentiation 8 (CD8+)T,T helper cell 1 (Th1)/ T helper cell 1(Th2),natural killer cell(NK),natural killer T(NK T),interleukin-1β(IL-1β),interleukin-4(IL-4),interleukin-6(IL-6),interleukin-8(IL-8),interleukin-12(IL-12),interleukin-15(IL-15),interleukin-17A(IL-17A),Tumor necrosis factor-alpha (TNF-α),Interferon-gamma (IFN-γ)

  7. complications [ Time Frame: Between 0 to 8 hours after MSC transfusion ]
    The occurrence of complications [including body temperature, tetter and allergy]

  8. The incidence of hepatocellular carcinoma [ Time Frame: 72 weeks after treatment ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18-65 years
  • Liver failure
  • Negative pregnancy test (female patients in fertile age)
  • Written consent
  • HBsAg positive
  • TB≥171 μmol/L or ascend ≥17.1 μmol/L/per day,
  • INR≥1.5 or 20%<PTA≤40%
  • 17≤MELD score≤30

Exclusion Criteria:

  • Hepatocellular carcinoma or other malignancies
  • Severe problems in other vital organs(e.g.the heart,renal or lungs)
  • Pregnant or lactating women
  • Severe bacteria infection
  • Anticipated with difficulty of follow-up observation
  • Liver failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on
  • Other candidates who are judged to be not applicable to this study by doctors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01844063


Contacts
Contact: Qihuan Xu, Doctor +86 20 85253179 xqh0303@yahoo.com
Contact: Qi Zhang, Doctor +86 20 85253106 kee_kee@126.com

Locations
China, Guangdong
Qi Zhang Recruiting
Guangzhou, Guangdong, China, 510630
Principal Investigator: Qi Zhang, Doctor         
Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
Investigators
Principal Investigator: Qi Zhang, Doctor Third Affiliated Hospital, Sun Yat-Sen University

Responsible Party: Qi Zhang, MD, Deputy Director, Office of International Cooperation & Exchange Office of Hongkong, Macao & Taiwan Affairs, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01844063     History of Changes
Other Study ID Numbers: The Third Affiliated Hospital
First Posted: May 1, 2013    Key Record Dates
Last Update Posted: July 8, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Antiviral Agents
Anti-Infective Agents