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

This study is not yet open for participant recruitment.
Verified April 2012 by Alliancells Bioscience Corporation Limited
Sponsor:
Information provided by (Responsible Party):
Alliancells Bioscience Corporation Limited
ClinicalTrials.gov Identifier:
NCT01573923
First received: April 6, 2012
Last updated: May 14, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Liver Cirrhosis
 Biological: mesenchymal stem cells
Biological: Conventional therapy
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Trial of Umbilical Mesenchymal Stem Cells Transplantation for Liver Cirrhosis-Phase I/II

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis Hepatitis
U.S. FDA Resources

Further study details as provided by Alliancells Bioscience Corporation Limited:

Primary Outcome Measures:
  • survival time [ Time Frame: 3-year follow up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum markers regarding liver and kidney function [ Time Frame: 0, 3, 6, 9 and 12 months ] [ Designated as safety issue: Yes ]
    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)

  • Serum markers regarding lipid and sugar profile [ Time Frame: 0, 3, 6, 9 and 12 months ] [ Designated as safety issue: Yes ]
    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;

  • Serum markers regarding cytokine profile [ Time Frame: 0, 3, 6, 9 and 12 months ] [ Designated as safety issue: Yes ]
    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)

  • Serum levels of Hepatitis B and C [ Time Frame: 0, 3, 6, 9 and 12 months ] [ Designated as safety issue: Yes ]
    Serum levels of Hepatitis B and C

  • tolerance and the adverse events [ Time Frame: 3-year follow up ] [ Designated as safety issue: Yes ]

    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.


  • Changes of any clinical symptoms [ Time Frame: 3-year follow up ] [ Designated as safety issue: Yes ]
    abdominal distension, appetite, debilitation, and edema of lower limbs.


Estimated Enrollment: 320
Study Start Date: July 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01573923

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

Locations
China, Beijing
The 302 Hospital of Chinese People's Liberation Army Not yet recruiting
Beijing, Beijing, China
Principal Investigator: Hanwei Li, MD, PhD            
China, Gansu
the First Affiliated Hospital of Lanzhou University Not yet recruiting
Lanzhou, Gansu, China
Contact: Xun Li, MD, PhD            
Principal Investigator: Xun Li, MD            
China, Jiangsu
The first people's hospital of Lianyungang Not yet recruiting
Lianyungang, Jiangsu, China, 222002
Contact: Hui Shi, MD            
Principal Investigator: Hui Shi, MD            
China, Shanghai
Tongji Hospital of Tongji University Not yet recruiting
Shanghai, Shanghai, China
Contact: Liming Chen, MD, PhD            
Principal Investigator: Jianwei Lu, PhD            
China, Shannxi
The 323 Hospital of Chinese People's Liberation Army Not yet recruiting
Xi'an, Shannxi, 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
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 The First Affiliated Hospital of Lanzhou University
Principal Investigator: Liming Chen, MD,PhD ongji Hospital of Tongji University
Principal Investigator: Jianwei Lu, MD Tongji Hospital of Tongji University
Principal Investigator: Hui Shi, MD The First People's Hospital of Lianyungang
  More Information

No publications provided

Responsible Party: Alliancells Bioscience Corporation Limited
ClinicalTrials.gov Identifier: NCT01573923     History of Changes
Other Study ID Numbers: Alliancells-2012-1
Study First Received: April 6, 2012
Last Updated: May 14, 2012
Health Authority: China: Ministry of Health

Keywords provided by Alliancells Bioscience Corporation Limited:
Umbilical Mesenchymal Stem Cells; Liver cirrhosis

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013