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

Ischemic Heart Failure Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01709279
• Other study ID #: 1133
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 16, 2012
• Last updated: August 15, 2017
• Start date: August 2012
• Est. completion date: September 2019

Study information

• Verified date: August 2017
• Source: Kanazawa University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 6
• Est. completion date: September 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Ischemia
• Ischemic Heart Failure

Intervention

Biological:
• adipose tissue derived stromal cells dosage
intra-coronary administration of autologous adipose tissue derived stroma cells

Locations

Country	Name	City	State
Japan	Kanazawa University Hospital	Kanazawa	Ishikawa

Sponsors (1)

Lead Sponsor	Collaborator
Kanazawa University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause harmful events		6 month