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Trial record 49 of 222 for:    umbilical cord mesenchymal stem cells

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.

Tracking Information
First Submitted Date  ICMJE April 21, 2011
First Posted Date  ICMJE April 27, 2011
Last Update Posted Date October 14, 2011
Study Start Date  ICMJE October 2010
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2011)
Overall Survival (OS) [ Time Frame: 1 year after treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01342250 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver Cirrhosis
Official Title  ICMJE Phase Ι/Π Study of Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver Cirrhosis
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.
Detailed Description To investigate the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation in patients of decompensated liver cirrhosis.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Liver Cirrhosis
Intervention  ICMJE
  • Biological: conventional therapy plus low dose hUC-MSCs treatment
    patients will receive the conventional therapy plus low dose hUC-MSCs treatment
  • Biological: conventional therapy plus medium dose hUC-MSCs treatment
    patients will receive conventional therapy plus medium dose hUC-MSCs treatment
  • Biological: conventional therapy plus high dose hUC-MSCs treatment
    patients will receive conventional therapy plus high dose hUC-MSCs treatment
Study Arms  ICMJE
  • Experimental: Conventional plus hUC-MSCs treatment (low dose)
    Intervention: Biological: conventional therapy plus low dose hUC-MSCs treatment
  • Experimental: conventional therapy plus hUC-MSCs treatment (medium dose)
    Intervention: Biological: conventional therapy plus medium dose hUC-MSCs treatment
  • Experimental: conventional therapy plus hUC-MSCs treatment (high dose)
    Intervention: Biological: conventional therapy plus high dose hUC-MSCs treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 13, 2011)
20
Original Estimated Enrollment  ICMJE
 (submitted: April 25, 2011)
50
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01342250
Other Study ID Numbers  ICMJE BKCR-LD-1.0(2010)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shenzhen Beike Bio-Technology Co., Ltd.
Study Sponsor  ICMJE Shenzhen Beike Bio-Technology Co., Ltd.
Collaborators  ICMJE No.85 Hospital, Changning, Shanghai, China
Investigators  ICMJE
Principal Investigator: Chengwei Chen No.85 Hospital, Changning, Shanghai, China
PRS Account Shenzhen Beike Bio-Technology Co., Ltd.
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP