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

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ClinicalTrials.gov Identifier: NCT01709279
Recruitment Status : Enrolling by invitation
First Posted : October 18, 2012
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):
Shuichi Kaneko, Kanazawa University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ischemic Heart Failure Biological: adipose tissue derived stromal cells dosage Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2012
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
adipose tissue derived stromal cells Biological: adipose tissue derived stromal cells dosage
intra-coronary administration of autologous adipose tissue derived stroma cells


Outcome Measures
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Primary Outcome Measures :
  1. all cause harmful events [ Time Frame: 6 month ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01709279


Locations
Japan
Kanazawa University Hospital
Kanazawa, Ishikawa, Japan, 920-8641
Sponsors and Collaborators
Kanazawa University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Shuichi Kaneko, Professor, Kanazawa University
ClinicalTrials.gov Identifier: NCT01709279     History of Changes
Other Study ID Numbers: 1133
First Posted: October 18, 2012    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017

Keywords provided by Shuichi Kaneko, Kanazawa University:
Ischemic heart failure
Myocardial regeneration
ADRC

Additional relevant MeSH terms:
Heart Failure
Ischemia
Heart Diseases
Cardiovascular Diseases
Pathologic Processes