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

Cytori Therapeutics

Status: Withdrawn

Conditions: Coronary Artery Disease; Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT02735993

CREATE

Details and patient eligibility

About

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.

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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.