NCT00913289

Brief Summary

Mesenchymal stem cells have the capability to differentiate into hepatocytes and will be useful for liver regeneration. Adipose tissue is relatively enriched with mesenchymal stem cells compared to bone marrow tissue. In this trial, eligible liver cirrhosis patients will receive autologous adipose tissue derived stromal cells which include such mesenchymal stem cells.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 4, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

October 18, 2012

Status Verified

October 1, 2012

Enrollment Period

1.2 years

First QC Date

June 3, 2009

Last Update Submit

October 16, 2012

Conditions

Liver Cirrhosis

Keywords

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • all cause harmful events

    6 months

Study Arms (1)

adipose tissue derived stromal cells

OTHER
Biological: adipose tissue derived stromal cells

Interventions

adipose tissue derived stromal cellsBIOLOGICAL

dosage

adipose tissue derived stromal cells

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Liver cirrhosis patients
  • Platelets count in peripheral blood: over 7.0x10\^4/microliter
  • Serum creatinine: less than 1.5 mg/dl
  • Capable of understanding the features of this clinical trial

You may not qualify if:

  • Associated with risky gastroesophageal varices for bleeding
  • Severe portal hypertension
  • Complicated with severe heart failure
  • Renal disease
  • Respiratory disease
  • Hematological disease
  • Coagulation disturbance and judged to be excluded by doctors
  • Associated with malignancy
  • Past history of the following:
  • malignancy
  • ischemic heart disease
  • cerebrovascular disease (cerebral infarction, cerebral hemorrhage)
  • decompensated status of liver cirrhosis
  • Pregnant, or possibility of pregnancy
  • Infected with HIV
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Shuichi Kaneko, M.D.

    Kanazawa University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 3, 2009

First Posted

June 4, 2009

Study Start

February 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

October 18, 2012

Record last verified: 2012-10

Locations

JP(1)