Cardiac REgistry of Celution Device for the Processing of Adipose-derived Regenerative Cells

Cardiac REgistry of Celution Device for the Processing of Adipose-derived Regenerative Cells: Treatment and Evaluation (CREATE)

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02735993

Acronym

CREATE

Enrollment

Registered

2016-04-13

Start date

2014-10-31

Completion date

2020-03-31

Last updated

2016-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Heart Failure

Keywords

Celution, ADRC, Heart Failure, Device

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change in the Minnesota Living with Heart Failure Questionnaire.	6 months

Secondary

Measure	Time frame	Description
LVESV/LVEDV	Day 180	Left ventricular function assessed by contrast Echocardiography
Heart Failure Symptoms	Days 90, 180 and 360	Heart Failure Symptoms as assessed by New York Heart Association (NYHA) Functional Classification
Treadmill exercise test	Day 180	—
Angina Symptoms	Days 90, 180 and 360	Angina Symptoms as measured by Canadian Cardiovascular Society Grading System for exertion-induced angina
LVEF assessed by contrast Echocardiography	Day 180	Left ventricular function assessed by contrast Echocardiography

Other

Measure	Time frame
MACEs defined as cardiac death, myocardial infarction or hospitalization for heart failure.	Ongoing evaluation from Day 1 through Month 60

Outcome results