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

Tracking Information
First Received Date ^ICMJE	October 16, 2012
Last Updated Date	October 16, 2012
Start Date ^ICMJE	August 2012
Estimated Primary Completion Date	August 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 16, 2012)	all cause harmful events [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Clinical Trial of Autologous Adipose Tissue Derived Stromal Cell Therapy for Ischemic Heart Failure
Official Title ^ICMJE	Not Provided
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.
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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Ischemic Heart Failure
Intervention ^ICMJE	Biological: adipose tissue derived stromal cells dosage intra-coronary administration of autologous adipose tissue derived stroma cells
Study Arm (s)	adipose tissue derived stromal cells Intervention: Biological: adipose tissue derived stromal cells dosage
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	6
Estimated Completion Date	September 2014
Estimated Primary Completion Date	August 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	20 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Japan

Administrative Information
NCT Number ^ICMJE	NCT01709279
Other Study ID Numbers ^ICMJE	1133
Has Data Monitoring Committee	No
Responsible Party	Shuichi Kaneko, Kanazawa University
Study Sponsor ^ICMJE	Kanazawa University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Kanazawa University
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top