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

Cytori Therapeutics0 sitesOctober 2014

ConditionsHeart Failure Coronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Cytori Therapeutics
Primary Endpoint: Change in the Minnesota Living with Heart Failure Questionnaire.
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2014

End Date

March 2020

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Cytori Therapeutics

Responsible Party

Sponsor

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.