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

Not Applicable

• Conditions: Ischemic Heart Failure
• Interventions: Biological: adipose tissue derived stromal cells dosage

• Registration Number: NCT01709279
• Lead Sponsor: Kanazawa University

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 Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-10-16
• Study First Submitted QC: 2012-10-16
• Study First Posted: 2012-10-18
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-15
• Last Update Posted: 2017-08-18
• Primary Completion: 2019-08
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
adipose tissue derived stromal cells	adipose tissue derived stromal cells dosage	-

Primary Outcome Measures

Name	Time	Method
all cause harmful events	6 month

Trial Locations

Locations (1)

Kanazawa University Hospital; 🇯🇵 Kanazawa, Ishikawa, Japan