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Safety and Efficacy Study of Umbilical Mesenchymal Stem Cells for Liver Cirrhosis (LC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01573923
Recruitment Status : Unknown
Verified April 2012 by Alliancells Bioscience Corporation Limited.
Recruitment status was:  Recruiting
First Posted : April 10, 2012
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
Alliancells Bioscience Corporation Limited

Study Description
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Brief Summary:
Liver cirrhosis and subsequent liver failure are leading causes of morbidity and mortality worldwide. Alcohol abuse and viral hepatitis are the most common causes of cirrhosis. Novel therapies are necessary to prevent or block the process of the disease. In this current prospective cohort, the investigators plan to organize four hospitals to determine the safety and efficacy of intravenous administration of umbilical mesenchymal stem cells in the treatment of patients with liver cirrhosis in next three years.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Biological: mesenchymal stem cells Biological: Conventional therapy Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial of Umbilical Mesenchymal Stem Cells Transplantation for Liver Cirrhosis-Phase I/II
Study Start Date : July 2014
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: Conventional therapy
only apply for conventional medical therapy without any cell therapy
 Biological: Conventional therapy
Conventional therapy without cell therapy
Active Comparator: mesenchymal stem cells
combination of conventional therapy with umbilical mesenchymal stem cells intravenous injection, (4x107/40ml, once per three months, four times in one year)
 Biological: mesenchymal stem cells
Conventional therapy plus UC-MSC intravenous administration (4x107/40ml, once per three months, four times in one year)


Outcome Measures
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Primary Outcome Measures :
  1. survival time [ Time Frame: 3-year follow up ]

Secondary Outcome Measures :
  1. Serum markers regarding liver and kidney function [ Time Frame: 0, 3, 6, 9 and 12 months ]
    liver functions：Albumin (ALB), Alanine aminotransferase (ALT), Aspartate Aminotransferase (AST), Prealbumin(PA), total bilirubin (TB), and direct bilirubin (DB) kidney function：Blood urea nitrogen (BUN), Urea (UA), and Crea (Cr)

  2. Serum markers regarding lipid and sugar profile [ Time Frame: 0, 3, 6, 9 and 12 months ]
    Total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglycerides (TG), very low density lipoprotein cholesterol (VLDL-C), and Non-HDL-C; blood sugar;

  3. Serum markers regarding cytokine profile [ Time Frame: 0, 3, 6, 9 and 12 months ]
    IL-1β, IL-4, IL-6, IL-8, IL-10, IL-12(p40), IL-15, IL-17A, TNFα, TNFβ, IFN-γ, RANTES, TGFβ, lymphotactin, and C-reactive protein level (CRP)

  4. Serum levels of Hepatitis B and C [ Time Frame: 0, 3, 6, 9 and 12 months ]
    Serum levels of Hepatitis B and C

  5. tolerance and the adverse events [ Time Frame: 3-year follow up ]

    The classification for uncomfortable reaction is: 0, no discomfort; 1, slightly unwell, does not affect daily life; 2, moderate discomfort, affects daily life and work; 3, moderately unwell, significantly affects life, and bed rest; 4, severely unwell, life-threatening.

    A serious adverse event is defined as fatal, life threatening, permanently disabling, and tumors, particularly hepatocellular carcinoma.


  6. Changes of any clinical symptoms [ Time Frame: 3-year follow up ]
    abdominal distension, appetite, debilitation, and edema of lower limbs.


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • written informed consent
  • aged 30-60 years
  • clinical diagnosis of compensated or decompensated liver
  • child-Pugh B/C (7-12 points)
  • expecting lifetime is over three years

Exclusion Criteria:

  • pregnant woman
  • patient with severe vascular diseases
  • patient with any organ failure
  • patient with any tumors
  • patient with HIV
  • patient who has been transplanted
  • patient treated with immunosuppressors
  • patient for whom the follow-up is considered impossible
  • patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
Contacts and Locations
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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): NCT01573923


Contacts
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Contact: Xuetao Pei, MD,PhD 86-10-68214650 peixt@nic.bmi.ac.cn
Contact: Haijie Ji, MD 86-10-63188853 jihaijie82@sohu.com

Locations
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China, Beijing
The 302 Hospital of Chinese People's Liberation Army Recruiting
Beijing, Beijing, China
Principal Investigator: Hanwei Li, MD, PhD         
China, Gansu
the First Affiliated Hospital of Lanzhou University Recruiting
Lanzhou, Gansu, China
Contact: Xun Li, MD, PhD         
Principal Investigator: Xun Li, MD         
China, Hainan
Hainan BOAO Life infinity international anti-aging medical center Recruiting
Qionghai, Hainan, China, 571434
Contact: Jiang Shu       Jiang.st@hotmail.com   
China, Jiangsu
The first people's hospital of Lianyungang Recruiting
Lianyungang, Jiangsu, China, 222002
Contact: Hui Shi, MD         
Principal Investigator: Hui Shi, MD         
China, Shanghai
Tongji Hospital of Tongji University Recruiting
Shanghai, Shanghai, China
Contact: Liming Chen, MD, PhD         
Principal Investigator: Jianwei Lu, PhD         
China, Shanxi
The 323 Hospital of Chinese People's Liberation Army Recruiting
Xi'an, Shanxi, China, 710054
Contact: Liming Wang, MD    86-29-84756502    wanglm@fmmu.edu.cn   
Principal Investigator: Liming Wang, MD         
Sponsors and Collaborators
Alliancells Bioscience Corporation Limited
Investigators
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Study Chair: Xuetao Pei, MD,PhD Chinese Industry and Innovative Technology Strategic Alliance of Stem Cells and Regenerative Medicine
Study Director: Yongjun Liu, MD,PhD Alliancells Bioscience Corporation Limited
Study Director: Mingyuan Wu, MD,PhD Eastern Union Stem Cell & Gene Engineering Co.,Ltd， Alliancells Bioscience Corporation Limited
Principal Investigator: Hanwei Li, MD,PhD The 302 Hospital of Chinese People's Liberation Army
Principal Investigator: Liming Wang, MD The 323 Hospital of Chinese People's Liberation Army
Principal Investigator: Xun Li, MD,PhD LanZhou University
Principal Investigator: Liming Chen, MD,PhD ongji Hospital of Tongji University
Principal Investigator: Jianwei Lu, MD Tongji Hospital
Principal Investigator: Hui Shi, MD The First People's Hospital of Lianyungang
More Information
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Responsible Party: Alliancells Bioscience Corporation Limited
ClinicalTrials.gov Identifier: NCT01573923    
Other Study ID Numbers: Alliancells-2012-1
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: April 2012
Keywords provided by Alliancells Bioscience Corporation Limited:
Umbilical Mesenchymal Stem Cells; Liver cirrhosis
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases