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

April 7, 2016 updated by: Cytori Therapeutics

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

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.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with heart failure due to non-ischemic disease (idiopathic cardiomyopathy) or coronary artery disease (CAD) that can not be revascularized.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the Minnesota Living with Heart Failure Questionnaire.
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cytori Therapeutics

Investigators

  • Study Chair: Steven Kesten, Cytori Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

March 15, 2016

First Submitted That Met QC Criteria

April 7, 2016

First Posted (Estimate)

April 13, 2016

Study Record Updates

Last Update Posted (Estimate)

April 13, 2016

Last Update Submitted That Met QC Criteria

April 7, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREATE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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