NCT01709279

Brief Summary

Mesenchymal stem cells have capability to differentiate into myocardium, vascular endothelial cell, vascular smooth muscle cell and will be useful for heart regeneration. Adipose tissue is relatively enriched with mesenchymal stem cell compared to bone marrow tissue. In this trial, eligible ischemic heart failure patients will be proceeded intracoronary administration of autologous adipose tissue derived stromal cells by cardiac catheterization.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2012

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

August 18, 2017

Status Verified

August 1, 2017

Enrollment Period

7 years

First QC Date

October 16, 2012

Last Update Submit

August 15, 2017

Conditions

Ischemic Heart Failure

Keywords

Ischemic heart failureMyocardial regenerationADRC

Outcome Measures

Primary Outcomes (1)

  • all cause harmful events

    6 month

Study Arms (1)

adipose tissue derived stromal cells

OTHER
Biological: adipose tissue derived stromal cells dosage

Interventions

adipose tissue derived stromal cells dosageBIOLOGICAL

intra-coronary administration of autologous adipose tissue derived stroma cells

adipose tissue derived stromal cells

Eligibility Criteria

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

You may qualify if:

  • Heart failure patients occured by prior ischemic event whose ejection fraction must be less than 40%.

You may not qualify if:

  • Complicated severe other organ disease.
  • Patient with malignancy.
  • History of chemotherapy or irradiation within 4 weeks.
  • Patient with immunodeficiency
  • Pregnancy or possibility of pregnancy
  • Candidate who are judged to be not applicable to this study by doctors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

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

October 16, 2012

First Posted

October 18, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2019

Study Completion

September 1, 2019

Last Updated

August 18, 2017

Record last verified: 2017-08

Locations

JP(1)