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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01342250
First Posted: April 27, 2011
Last Update Posted: October 14, 2011
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.
Collaborator:
No.85 Hospital, Changning, Shanghai, China
Information provided by (Responsible Party):
Shenzhen Beike Bio-Technology Co., Ltd.
  Purpose
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 Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Shenzhen Beike Bio-Technology Co., Ltd.:

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

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

Enrollment: 20
Study Start Date: October 2010
Study Completion Date: October 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
To investigate the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation in patients of decompensated liver cirrhosis.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
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
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
Principal Investigator: Chengwei Chen No.85 Hospital, Changning, Shanghai, China
  More Information

Responsible Party: Shenzhen Beike Bio-Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT01342250     History of Changes
Other Study ID Numbers: BKCR-LD-1.0(2010)
First Submitted: April 21, 2011
First Posted: April 27, 2011
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:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases