Heart FailureCREATENCT02735993
Cardiac REgistry of Celution Device for the Processing of Adipose-derived Regenerative Cells
An observational study of Heart Failure and Coronary Artery Disease, run by Cytori Therapeutics.
Trial summary
This cardiac registry study will collect information from patients with ischemic or non-ischemic heart failure that have been treated with adipose-derived regenerative cells (ADRCs) delivered via intramyocardial injection. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Heart Failure, Coronary Artery Disease
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Mar 2020
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with heart failure due to non-ischemic disease (idiopathic cardiomyopathy) or coronary artery disease (CAD) that can not be revascularized.
Who may be able to join
- Males or females > 20 and < 80 years of age
- Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization OR idiopathic dilated cardiomyopathy
- Symptoms of heart failure (e.g. NYHA Stages of Heart Failure Class II or III)
- On maximal medical therapy for heart failure and if present, anginal symptoms
- Hemodynamic stability (SBP ≥ 90 mm/Hg, HR <110 beats/min)
- Ejection fraction ≤ 45%
- Left ventricular wall thickness > 5 mm at the target site(s) for cell injection, confirmed by Contrast Echo within 4 weeks prior to enrollment, and free of thrombus
Who cannot join
- Vascular anatomy and/or peripheral artery disease that prevents or impedes cardiac catheterization
- Aortic or mitral valve disease where valve replacement is indicated
- Presence of mechanical aortic or mitral valves
- Presence of aortic dissection
- Planned staged treatment of CAD or other therapeutic intervention on the heart within the subsequent 3 months
- TIA or stroke within 30 days prior to the procedure
Show all 10Show fewer
- ICD placement or ablation therapy within 30 days prior to the procedure
- Acute coronary syndrome (ACS) or a myocardial infarction in the 30 days prior to the procedure
- Revascularization within 30 days prior to intramyocardial injection of ADRCs
- Pregnant or lactating status. Pregnancy as determined by a positive pregnancy test at screening or baseline.
About this study
Official title: Cardiac REgistry of Celution Device for the Processing of Adipose-derived Regenerative Cells: Treatment and Evaluation (CREATE)
This cardiac registry study will collect information from patients with ischemic or non-ischemic heart failure that have been treated with adipose-derived regenerative cells (ADRCs) delivered via intramyocardial injection.
- Conditions
- Heart Failure, Coronary Artery Disease
- Keywords
- Celution, ADRC, Heart Failure, Device
- Medical subject headings
- Heart Failure, Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Minnesota Living with Heart Failure Questionnaire.
Measured: 6 months
Secondary outcomes (5)
Heart Failure Symptoms
Heart Failure Symptoms as assessed by New York Heart Association (NYHA) Functional Classification
Measured: Days 90, 180 and 360
LVESV/LVEDV
Left ventricular function assessed by contrast Echocardiography
Measured: Day 180
LVEF assessed by contrast Echocardiography
Left ventricular function assessed by contrast Echocardiography
Measured: Day 180
Treadmill exercise test
Measured: Day 180
Angina Symptoms
Angina Symptoms as measured by Canadian Cardiovascular Society Grading System for exertion-induced angina
Measured: Days 90, 180 and 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startOct 2014
- Primary completionDec 2016 (estimated)
- Study completionMar 2020 (estimated)
Why it stopped: Corporate decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Cytori Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Kesten, Study chair, Cytori Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735993
- Sponsor's protocol ID
- CREATE
- Acronym
- CREATE
- Status last verified
- Apr 2016
- First submitted
- 15 Mar 2016
- Last updated
- 13 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac REgistry of Celution Device for the Processing of Adipose-derived Regenerative Cells: Treatment and Evaluation (CREATE)
- ClinicalTrials.gov ID
- NCT02735993
- Acronym / sponsor ID
- CREATE / CREATE
- Conditions
- Heart Failure, Coronary Artery Disease
- Keywords
- Celution, ADRC, Heart Failure, Device
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Corporate decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cytori TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 13 Apr 2016 (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.
This cardiac registry study will collect information from patients with ischemic or non-ischemic heart failure that have been treated with adipose-derived regenerative cells (ADRCs) delivered via intramyocardial injection.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with heart failure due to non-ischemic disease (idiopathic cardiomyopathy) or coronary artery disease (CAD) that can not be revascularized.
Key inclusion criteria (7 listed)
- Males or females > 20 and < 80 years of age
- Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization OR idiopathic dilated cardiomyopathy
- Symptoms of heart failure (e.g. NYHA Stages of Heart Failure Class II or III)
- On maximal medical therapy for heart failure and if present, anginal symptoms
- Hemodynamic stability (SBP ≥ 90 mm/Hg, HR <110 beats/min)
Key exclusion criteria (10 listed)
- Vascular anatomy and/or peripheral artery disease that prevents or impedes cardiac catheterization
- Aortic or mitral valve disease where valve replacement is indicated
- Presence of mechanical aortic or mitral valves
- Presence of aortic dissection
- Planned staged treatment of CAD or other therapeutic intervention on the heart within the subsequent 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in the Minnesota Living with Heart Failure Questionnaire.
Time frame: 6 months
5 secondary outcomes
Heart Failure Symptoms
Time frame: Days 90, 180 and 360
LVESV/LVEDV
Time frame: Day 180
LVEF assessed by contrast Echocardiography
Time frame: Day 180
Treadmill exercise test
Time frame: Day 180
Angina Symptoms
Time frame: Days 90, 180 and 360
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
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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.
Steven Kesten study chair
Cytori Therapeutics
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Coronary Artery Disease, run by Cytori Therapeutics.
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 7 inclusion and 10 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: withdrawn, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in the Minnesota Living with Heart Failure Questionnaire. (time frame: 6 months). 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 13 Apr 2016.