Clinical Trial of Autologous Adipose Tissue Derived Stromal Cell Therapy for Ischemic Heart Failure

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

Shuichi Kaneko, Kanazawa University

ClinicalTrials.gov Identifier:

NCT01709279

First received: October 16, 2012

Last updated: NA

Last verified: October 2012

History: No changes posted

Purpose

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.

Condition	Intervention
Ischemic Heart Failure	Biological: adipose tissue derived stromal cells dosage


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Kanazawa University:

Primary Outcome Measures:

all cause harmful events [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	6
Study Start Date:	August 2012
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
adipose tissue derived stromal cells	Biological: adipose tissue derived stromal cells dosage intra-coronary administration of autologous adipose tissue derived stroma cells

Detailed Description:

The population of the ischemic heart failure patients is enormous in Japan and the only radical treatment for them is heart transplantation: however, the number of giving donor is extremely limited. Mesenchymal stem cells have been capable to differentiate into mesodermal-lineage cells as well as endodermal-lineage cells such as myocardial cell. They reside in the mesenchymal tissues such as bone marrows as well as adipose tissues. The latter tissues are relatively enriched with mesenchymal stem cells compared to bone marrow cells. In this study, the ischemic heart failure patients will undergo intracoronary administration of autologous adipose tissue derived stromal cells through cardiac catheterization.

Eligibility


Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709279

Locations


Japan
Kanazawa University Hospital
Kanazawa, Ishikawa, Japan, 920-8641

Sponsors and Collaborators

Kanazawa University

More Information

No publications provided


Responsible Party:	Shuichi Kaneko, Professor, Kanazawa University
ClinicalTrials.gov Identifier:	NCT01709279 History of Changes
Other Study ID Numbers:	1133
Study First Received:	October 16, 2012
Last Updated:	October 16, 2012
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kanazawa University:


Ischemic heart failure Myocardial regeneration ADRC

Additional relevant MeSH terms:


Heart Failure Cardiovascular Diseases Heart Diseases

ClinicalTrials.gov processed this record on February 27, 2015

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