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

October 16, 2012
October 16, 2012
August 2012
August 2014   (final data collection date for primary outcome measure)
all cause harmful events [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Trial of Autologous Adipose Tissue Derived Stromal Cell Therapy for Ischemic Heart Failure
Not Provided

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ischemic Heart Failure
Biological: adipose tissue derived stromal cells dosage
intra-coronary administration of autologous adipose tissue derived stroma cells
adipose tissue derived stromal cells
Intervention: Biological: adipose tissue derived stromal cells dosage
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
6
September 2014
August 2014   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01709279
1133
No
Shuichi Kaneko, Kanazawa University
Kanazawa University
Not Provided
Not Provided
Kanazawa University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP