Ischemic Heart FailureNCT01709279
Clinical Trial of Autologous Adipose Tissue Derived Stromal Cell Therapy for Ischemic Heart Failure
A study testing adipose tissue derived stromal cells dosage in people with Ischemic Heart Failure, run by Kanazawa University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Ischemic Heart Failure
- What is being tested?
- adipose tissue derived stromal cells dosage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2012to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart failure patients occured by prior ischemic event whose ejection fraction must be less than 40%.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Ischemic Heart Failure
- Being tested
- adipose tissue derived stromal cells dosage
- Keywords
- Ischemic heart failure, Myocardial regeneration, ADRC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adipose tissue derived stromal cells dosageBiological
intra-coronary administration of autologous adipose tissue derived stroma cells
| Study group | Role | What they receive |
|---|---|---|
| adipose tissue derived stromal cells | Other | Not described Receives: Biological: adipose tissue derived stromal cells dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause harmful events
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanazawa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuichi Kaneko, Kanazawa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709279
- Sponsor's protocol ID
- 1133
- Status last verified
- Aug 2017
- First submitted
- 16 Oct 2012
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Autologous Adipose Tissue Derived Stromal Cell Therapy for Ischemic Heart Failure
- ClinicalTrials.gov ID
- NCT01709279
- Acronym / sponsor ID
- 1133
- Conditions
- Ischemic Heart Failure
- Keywords
- Ischemic heart failure, Myocardial regeneration, ADRC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Kanazawa UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 18 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adipose tissue derived stromal cells | Other | Biological: adipose tissue derived stromal cells dosage |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Heart failure patients occured by prior ischemic event whose ejection fraction must be less than 40%.
Key exclusion criteria (6 listed)
- Complicated severe other organ disease.
- Patient with malignancy.
- History of chemotherapy or irradiation within 4 weeks.
- Patient with immunodeficiency
- Pregnancy or possibility of pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adipose tissue derived stromal cells dosageintra-coronary administration of autologous adipose tissue derived stroma cells | Biological | adipose tissue derived stromal cells |
Primary outcome
all cause harmful events
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adipose tissue derived stromal cells dosage in people with Ischemic Heart Failure, run by Kanazawa University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause harmful events (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.