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

Primary Purpose

Ischemic Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
adipose tissue derived stromal cells dosage
Sponsored by
Kanazawa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Failure focused on measuring Ischemic heart failure, Myocardial regeneration, ADRC

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kanazawa University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

adipose tissue derived stromal cells

Arm Description

Outcomes

Primary Outcome Measures

all cause harmful events

Secondary Outcome Measures

Full Information

First Posted
October 16, 2012
Last Updated
August 15, 2017
Sponsor
Kanazawa University
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1. Study Identification

Unique Protocol Identification Number
NCT01709279
Brief Title
Clinical Trial of Autologous Adipose Tissue Derived Stromal Cell Therapy for Ischemic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanazawa University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Failure
Keywords
Ischemic heart failure, Myocardial regeneration, ADRC

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
adipose tissue derived stromal cells
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
adipose tissue derived stromal cells dosage
Intervention Description
intra-coronary administration of autologous adipose tissue derived stroma cells
Primary Outcome Measure Information:
Title
all cause harmful events
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Kanazawa University Hospital
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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