- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01709279
Clinical Trial of Autologous Adipose Tissue Derived Stromal Cell Therapy for Ischemic Heart Failure
August 15, 2017 updated by: Shuichi Kaneko, Kanazawa University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ishikawa
-
Kanazawa, Ishikawa, Japan, 920-8641
- Kanazawa University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: adipose tissue derived stromal cells
|
intra-coronary administration of autologous adipose tissue derived stroma cells
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
all cause harmful events
Time Frame: 6 month
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Anticipated)
August 1, 2019
Study Completion (Anticipated)
September 1, 2019
Study Registration Dates
First Submitted
October 16, 2012
First Submitted That Met QC Criteria
October 16, 2012
First Posted (Estimate)
October 18, 2012
Study Record Updates
Last Update Posted (Actual)
August 18, 2017
Last Update Submitted That Met QC Criteria
August 15, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1133
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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