NCT01342250

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 27, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 14, 2011

Status Verified

October 1, 2011

Enrollment Period

9 months

First QC Date

April 21, 2011

Last Update Submit

October 13, 2011

Conditions

Liver Cirrhosis

Keywords

Decompensated Liver CirrhosisUmbilical Cord Mesenchymal Stem Cells

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    1 year after treatment

Secondary Outcomes (5)

  • Liver function improvement

    1 year after treatment

  • The size of liver and the width of portal venous

    1 year after treatment

  • Incidence of hepatocellular carcinoma within 1 year

    1 year after treatment

  • Child-Pugh score, MELD score,SF36-quality of life (SF36-QOL)

    1 year after treatment

  • The clinical symptom improvement(including appetite, debilitation, abdominal distension, edema of lower limbs, et al )

    1 year after treatment

Study Arms (3)

Conventional plus hUC-MSCs treatment (low dose)

EXPERIMENTAL
Biological: conventional therapy plus low dose hUC-MSCs treatment

conventional therapy plus hUC-MSCs treatment （medium dose）

EXPERIMENTAL
Biological: conventional therapy plus medium dose hUC-MSCs treatment

conventional therapy plus hUC-MSCs treatment （high dose）

EXPERIMENTAL
Biological: conventional therapy plus high dose hUC-MSCs treatment

Interventions

conventional therapy plus low dose hUC-MSCs treatmentBIOLOGICAL

patients will receive the conventional therapy plus low dose hUC-MSCs treatment

Conventional plus hUC-MSCs treatment (low dose)
conventional therapy plus medium dose hUC-MSCs treatmentBIOLOGICAL

patients will receive conventional therapy plus medium dose hUC-MSCs treatment

conventional therapy plus hUC-MSCs treatment （medium dose）
conventional therapy plus high dose hUC-MSCs treatmentBIOLOGICAL

patients will receive conventional therapy plus high dose hUC-MSCs treatment

conventional therapy plus hUC-MSCs treatment （high dose）

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200235, China

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chengwei Chen

    No.85 Hospital, Changning, Shanghai, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2011

First Posted

April 27, 2011

Study Start

October 1, 2010

Primary Completion

July 1, 2011

Study Completion

October 1, 2011

Last Updated

October 14, 2011

Record last verified: 2011-10

Locations

CN(1)