NCT01062750

Brief Summary

Mesenchymal stem cells have capability to differentiate into hepatocyte and will be useful for liver regeneration. Adipose tissue is relatively enriched with mesenchymal stem cell compared to bone marrow tissue. In this trial, eligible liver cirrhosis patients will receive autologous adipose tissue derived stromal cells through intrahepatic arterial catheterization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2010

Completed
2.7 years until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

September 7, 2015

Status Verified

September 1, 2015

Enrollment Period

2.3 years

First QC Date

February 3, 2010

Last Update Submit

September 4, 2015

Conditions

Liver Cirrhosis

Keywords

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • all cause harmful events

    one month

Study Arms (1)

adipose tissue derived stromal cells

OTHER
Biological: adipose tissue derived stromal cells dosage

Interventions

adipose tissue derived stromal cells dosageBIOLOGICAL

single administration of autologous adipose tissue derived stroma cells via intrahepatic arterial catheterization

adipose tissue derived stromal cells

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Criteria defined in the implementation protocol

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

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
not applicable
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

February 3, 2010

First Posted

February 4, 2010

Study Start

October 1, 2012

Primary Completion

February 1, 2015

Study Completion

May 1, 2015

Last Updated

September 7, 2015

Record last verified: 2015-09

Locations

JP(1)