Clinical trial NCT02735993: Cardiac REgistry of Celution Device for the Processing of Adipose-derived Regenerative Cells
Official title: Cardiac REgistry of Celution Device for the Processing of Adipose-derived Regenerative Cells: Treatment and Evaluation (CREATE)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Heart Failure
Coronary Artery Disease
Keywords: Celution
ADRC
Heart Failure
Device
Lead sponsor: Cytori Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-04-13
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with heart failure due to non-ischemic disease (idiopathic cardiomyopathy) or coronary artery disease (CAD) that can not be revascularized.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: Change in the Minnesota Living with Heart Failure Questionnaire.
timeFrame: 6 months
Secondary outcomes:
measure: Heart Failure Symptoms
timeFrame: Days 90, 180 and 360
measure: LVESV/LVEDV
timeFrame: Day 180
measure: LVEF assessed by contrast Echocardiography
timeFrame: Day 180
measure: Treadmill exercise test
timeFrame: Day 180
measure: Angina Symptoms
timeFrame: Days 90, 180 and 360
Other outcomes:
measure: MACEs defined as cardiac death, myocardial infarction or hospitalization for heart failure.
timeFrame: Ongoing evaluation from Day 1 through Month 60
Locations:
Study officials:
affiliation: Cytori Therapeutics
name: Steven Kesten
role: STUDY_CHAIR
References: