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Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver Cirrhosis

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: NCT01342250
Recruitment Status : Completed
First Posted : April 27, 2011
Last Update Posted : October 14, 2011
Sponsor:
Collaborator:
No.85 Hospital, Changning, Shanghai, China
Information provided by (Responsible Party):
Shenzhen Beike Bio-Technology Co., Ltd.

Study Description
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Brief Summary:
Although liver transplantation provide a option to cure patients suffering with decompensated liver cirrhosis this condition, lack of donors, postoperative complications, especially rejection, and high cost limit its application. Bone marrow derived mesenchymal stem cells (BM-MSCs) have been shown to replace hepatocytes in injured liver, effectively rescued experimental liver failure and contributed to liver regeneration, which suggest the novel and promising therapeutic strategy In this study, the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSCs) transplantation for patients with decompensated liver cirrhosis will be evaluated.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Biological: conventional therapy plus low dose hUC-MSCs treatment Biological: conventional therapy plus medium dose hUC-MSCs treatment Biological: conventional therapy plus high dose hUC-MSCs treatment Phase 1 Phase 2

Detailed Description:
To investigate the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation in patients of decompensated liver cirrhosis.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ι/Π Study of Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver Cirrhosis
Study Start Date : October 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Conventional plus hUC-MSCs treatment (low dose) Biological: conventional therapy plus low dose hUC-MSCs treatment
patients will receive the conventional therapy plus low dose hUC-MSCs treatment
Experimental: conventional therapy plus hUC-MSCs treatment （medium dose） Biological: conventional therapy plus medium dose hUC-MSCs treatment
patients will receive conventional therapy plus medium dose hUC-MSCs treatment
Experimental: conventional therapy plus hUC-MSCs treatment （high dose） Biological: conventional therapy plus high dose hUC-MSCs treatment
patients will receive conventional therapy plus high dose hUC-MSCs treatment


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 1 year after treatment ]

Secondary Outcome Measures :
  1. Liver function improvement [ Time Frame: 1 year after treatment ]
  2. The size of liver and the width of portal venous [ Time Frame: 1 year after treatment ]
  3. Incidence of hepatocellular carcinoma within 1 year [ Time Frame: 1 year after treatment ]
  4. Child-Pugh score, MELD score,SF36-quality of life (SF36-QOL) [ Time Frame: 1 year after treatment ]
  5. The clinical symptom improvement(including appetite, debilitation, abdominal distension, edema of lower limbs, et al ) [ Time Frame: 1 year after treatment ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent.
  • Aged 18-70 years.
  • Decompensated liver cirrhosis, Child-Pugh B/C (7-12 points); or Meld score≦21.
  • Expecting lifetime is over 2 months.
  • Hepatitis B decompensated liver cirrhosis patients need antiviral therapy.

Exclusion Criteria:

  • Severe drug allergic history or anaphylaxis.
  • Severe problems in other vital organs(e.g. the heart, renal or lungs)
  • Severe problems in psychiatric disease,such as Schizophrenia,et al
  • Severe bacteria infection.
  • Malignancies.
  • Alcoholism or drug abuse.
  • Plan to have liver transplantation in 3 months.
  • Pregnancy
  • Candidates who are participating in other study.
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): NCT01342250


Locations
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China, Shanghai
Shanghai Liver Disease Research Center, the Nanjing Military Command (Shanghai 85 Hospital)
Shanghai, Shanghai, China, 200235
Sponsors and Collaborators
Shenzhen Beike Bio-Technology Co., Ltd.
No.85 Hospital, Changning, Shanghai, China
Investigators
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Principal Investigator: Chengwei Chen No.85 Hospital, Changning, Shanghai, China
More Information
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Responsible Party: Shenzhen Beike Bio-Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT01342250    
Other Study ID Numbers: BKCR-LD-1.0(2010)
First Posted: April 27, 2011    Key Record Dates
Last Update Posted: October 14, 2011
Last Verified: October 2011
Keywords provided by Shenzhen Beike Bio-Technology Co., Ltd.:
Decompensated Liver Cirrhosis
Umbilical Cord Mesenchymal Stem Cells
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases