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

Primary Purpose

Liver Cirrhosis

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
conventional therapy plus low dose hUC-MSCs treatment
conventional therapy plus medium dose hUC-MSCs treatment
conventional therapy plus high dose hUC-MSCs treatment
Sponsored by
Shenzhen Beike Bio-Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring Decompensated Liver Cirrhosis, Umbilical Cord Mesenchymal Stem Cells

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Liver Disease Research Center, the Nanjing Military Command (Shanghai 85 Hospital)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Conventional plus hUC-MSCs treatment (low dose)

conventional therapy plus hUC-MSCs treatment （medium dose）

conventional therapy plus hUC-MSCs treatment （high dose）

Arm Description

Outcomes

Primary Outcome Measures

Overall Survival (OS)

Secondary Outcome Measures

Liver function improvement
The size of liver and the width of portal venous
Incidence of hepatocellular carcinoma within 1 year
Child-Pugh score, MELD score,SF36-quality of life (SF36-QOL)
The clinical symptom improvement(including appetite, debilitation, abdominal distension, edema of lower limbs, et al )

Full Information

First Posted
April 21, 2011
Last Updated
October 13, 2011
Sponsor
Shenzhen Beike Bio-Technology Co., Ltd.
Collaborators
No.85 Hospital, Changning, Shanghai, China
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1. Study Identification

Unique Protocol Identification Number
NCT01342250
Brief Title
Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver Cirrhosis
Official Title
Phase Ι/Π Study of Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Beike Bio-Technology Co., Ltd.
Collaborators
No.85 Hospital, Changning, Shanghai, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
Keywords
Decompensated Liver Cirrhosis, Umbilical Cord Mesenchymal Stem Cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional plus hUC-MSCs treatment (low dose)
Arm Type
Experimental
Arm Title
conventional therapy plus hUC-MSCs treatment （medium dose）
Arm Type
Experimental
Arm Title
conventional therapy plus hUC-MSCs treatment （high dose）
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
conventional therapy plus low dose hUC-MSCs treatment
Intervention Description
patients will receive the conventional therapy plus low dose hUC-MSCs treatment
Intervention Type
Biological
Intervention Name(s)
conventional therapy plus medium dose hUC-MSCs treatment
Intervention Description
patients will receive conventional therapy plus medium dose hUC-MSCs treatment
Intervention Type
Biological
Intervention Name(s)
conventional therapy plus high dose hUC-MSCs treatment
Intervention Description
patients will receive conventional therapy plus high dose hUC-MSCs treatment
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
1 year after treatment
Secondary Outcome Measure Information:
Title
Liver function improvement
Time Frame
1 year after treatment
Title
The size of liver and the width of portal venous
Time Frame
1 year after treatment
Title
Incidence of hepatocellular carcinoma within 1 year
Time Frame
1 year after treatment
Title
Child-Pugh score, MELD score,SF36-quality of life (SF36-QOL)
Time Frame
1 year after treatment
Title
The clinical symptom improvement(including appetite, debilitation, abdominal distension, edema of lower limbs, et al )
Time Frame
1 year after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chengwei Chen
Organizational Affiliation
No.85 Hospital, Changning, Shanghai, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Liver Disease Research Center, the Nanjing Military Command (Shanghai 85 Hospital)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200235
Country
China

12. IPD Sharing Statement

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

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