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

Withdrawn

• Conditions: Coronary Artery Disease; Heart Failure

• Registration Number: NCT02735993
• Lead Sponsor: Cytori Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2016-03-15
• Status Verified: 2016-04
• Study First Submitted QC: 2016-04-07
• Last Update Submitted: 2016-04-07
• Study First Posted: 2016-04-13
• Last Update Posted: 2016-04-13
• Primary Completion: 2016-12
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the Minnesota Living with Heart Failure Questionnaire.	6 months

Secondary Outcome Measures

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