NCT02735993

Withdrawn

Cardiac REgistry of Celution Device for the Processing of Ad...

Cytori Therapeutics Source

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Other study identifiers

Sponsor study identifier

CREATE

Study Type

observational

Actual enrollment (reported)

0

Locations

0 countries

Sites

N/A

Timeline

Study Start

October 2014

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2016

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

March 2020

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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 Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: withdrawn
Actual enrollment (reported): 0 participants
Study completion date: March 2020
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 2014
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
March 15, 2016
Actual (reported)
First Posted
April 13, 2016
Actual (reported)
Primary Completion
December 2016
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2020
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: April 13, 2016
Status Verified: April 2016
Last Update Submitted: April 7, 2016

Conditions

Coronary Artery Disease Heart Failure

Keywords

CelutionADRCHeart FailureDevice

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

Heart Failure Symptoms
Days 90, 180 and 360
LVESV/LVEDV
Day 180
LVEF assessed by contrast Echocardiography
Day 180
Treadmill exercise test
Day 180
Angina Symptoms
Days 90, 180 and 360

Other Outcomes (1)

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

Eligibility Criteria

Age20 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

You may qualify if:

Males or females \> 20 and \< 80 years of age

Sponsors & Collaborators

Cytori Therapeutics
Industrylead

MeSH Terms

Conditions

Heart FailureCoronary Artery Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

Steven Kesten
Cytori Therapeutics
STUDY CHAIR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Target Duration: 5 Years
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 15, 2016

First Posted

April 13, 2016

Study Start

October 2014

Date type not reported

This date has not been verified as actual or estimated.

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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

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Primary Completion

December 2016

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

March 2020

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

April 13, 2016

Record last verified: 2016-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02735993
Data provider: ClinicalTrials.gov
Source updated: 2016-04-13
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:21:12 UTC

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Other Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Other Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record