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

This study has been completed.
Sponsor:
Collaborator:
Shanghai 85 Hospital
Information provided by (Responsible Party):
Shenzhen Beike Bio-Technology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01342250
First received: April 21, 2011
Last updated: October 13, 2011
Last verified: October 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Liver function improvement [ Time Frame: 1 year after treatment ] [ Designated as safety issue: No ]
  • The size of liver and the width of portal venous [ Time Frame: 1 year after treatment ] [ Designated as safety issue: No ]
  • Incidence of hepatocellular carcinoma within 1 year [ Time Frame: 1 year after treatment ] [ Designated as safety issue: Yes ]
  • Child-Pugh score, MELD score,SF36-quality of life (SF36-QOL) [ Time Frame: 1 year after treatment ] [ Designated as safety issue: No ]
  • The clinical symptom improvement(including appetite, debilitation, abdominal distension, edema of lower limbs, et al ) [ Time Frame: 1 year after treatment ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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.
Shanghai 85 Hospital
Investigators
Principal Investigator: Chengwei Chen Shanghai Liver Disease Research Center, the Nanjing Military Command (Shanghai 85 Hospital)
  More Information

No publications provided

Responsible Party: Shenzhen Beike Bio-Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT01342250     History of Changes
Other Study ID Numbers: BKCR-LD-1.0(2010)
Study First Received: April 21, 2011
Last Updated: October 13, 2011
Health Authority: China: Ministry of Health

Keywords provided by Shenzhen Beike Bio-Technology Co., Ltd.:
Decompensated Liver Cirrhosis
Umbilical Cord Mesenchymal Stem Cells

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

ClinicalTrials.gov processed this record on April 23, 2014