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Clinical Trial of Autologous Adipose Tissue Derived Stromal Cell Therapy for Ischemic Heart Failure
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Shuichi Kaneko, Kanazawa University.
Recruitment status was: Enrolling by invitation
Recruitment status was: Enrolling by invitation
Sponsor:
Kanazawa University
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
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Purpose
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 | Intervention |
|---|---|
| Ischemic Heart Failure | Biological: adipose tissue derived stromal cells dosage |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Shuichi Kaneko, Kanazawa University:
Primary Outcome Measures:
- all cause harmful events [ Time Frame: 6 month ]
| Estimated Enrollment: | 6 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| adipose tissue derived stromal cells |
Biological: adipose tissue derived stromal cells dosage
intra-coronary administration of autologous adipose tissue derived stroma cells
|
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.
Eligibility| 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01709279
Please refer to this study by its ClinicalTrials.gov identifier: NCT01709279
Locations
| Japan | |
| Kanazawa University Hospital | |
| Kanazawa, Ishikawa, Japan, 920-8641 | |
Sponsors and Collaborators
Kanazawa University
More Information
| Responsible Party: | Shuichi Kaneko, Professor, Kanazawa University |
| ClinicalTrials.gov Identifier: | NCT01709279 History of Changes |
| Other Study ID Numbers: |
1133 |
| Study First Received: | October 16, 2012 |
| Last Updated: | October 16, 2012 |
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 |
ClinicalTrials.gov processed this record on June 23, 2017