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

Coronary Artery Disease Clinical Trial

— CREATE  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02735993
• Other study ID #: CREATE
• Status: Withdrawn
• Phase: N/A
• First received: March 15, 2016
• Last updated: April 7, 2016
• Start date: October 2014
• Est. completion date: March 2020

Study information

• Verified date: April 2016
• Source: Cytori Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2020
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Failure
• Myocardial Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cytori Therapeutics

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MACEs defined as cardiac death, myocardial infarction or hospitalization for heart failure.		Ongoing evaluation from Day 1 through Month 60	Yes
Primary	Change in the Minnesota Living with Heart Failure Questionnaire.		6 months	No
Secondary	Heart Failure Symptoms	Heart Failure Symptoms as assessed by New York Heart Association (NYHA) Functional Classification	Days 90, 180 and 360	No
Secondary	LVESV/LVEDV	Left ventricular function assessed by contrast Echocardiography	Day 180	No
Secondary	LVEF assessed by contrast Echocardiography	Left ventricular function assessed by contrast Echocardiography	Day 180	No
Secondary	Treadmill exercise test		Day 180	No
Secondary	Angina Symptoms	Angina Symptoms as measured by Canadian Cardiovascular Society Grading System for exertion-induced angina	Days 90, 180 and 360	No