NCT00346177

WithdrawnPhase 2

Stem Cell Study for Patients With Heart Failure

Losordo, Douglas, M.D.Source

Losordo, Douglas, M.D.

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

BB-IND-11196-02

Study Type

interventional

Estimated enrollment

30

Locations

1 country

Sites

1

Timeline

Study Start

September 2010

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2011

Estimated (date passed)

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

Study Completion

September 2012

Estimated (date passed)

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

Brief Summary

The purpose of this study is to determine if cell therapy with your own cells (autologous cells) delivered with a catheter to regions of the heart with poor blood flow will be safe and if it will improve your ejection fraction and heart failure symptoms.

Registry Overview

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

Recruitment status: withdrawn
Estimated enrollment: 30 participants
Study completion date: September 2012
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

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

First Submitted
June 27, 2006
Actual (reported)
First Posted
June 29, 2006
Actual (reported)
Study Start
September 2010
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
September 2011
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2012
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: September 14, 2010
Status Verified: September 2010
Last Update Submitted: September 10, 2010

Conditions

Cardiovascular Disease Congestive Heart Failure Myocardial Ischemia

Keywords

heartstem Cellslow EFheart attackcardiomyopathycongestive heart failurecardiovascular diseaseHeart FailureLow Ejection Fraction

Outcome Measures

Primary Outcomes (1)

The purpose of this study is to determine if cell therapy with your own cells (autologous cells) delivered with a catheter to regions of the heart with poor blood flow will be safe and if it will improve your ejection fraction and heart failure symptoms.
6 months

Study Arms (2)

1

ACTIVE COMPARATOR

Stem Cells

Biological: Autologous Stem Cells

2

PLACEBO COMPARATOR

Placebo

Biological: Autologous Stem Cells

Interventions

Autologous Stem CellsBiological

Intramyocardial injections

12

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age21 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Subjects greater than 21 years old.
Subjects with functional class (NYHA) III ischemic heart failure.

Sponsors & Collaborators

Losordo, Douglas, M.D.
Individuallead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

MeSH Terms

Conditions

Myocardial IschemiaHeart FailureCardiovascular DiseasesMyocardial InfarctionCardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

Douglas W. Losordo, M.D.
Northwestern University
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDIV

Study Record Dates

First Submitted

June 27, 2006

First Posted

June 29, 2006

Study Start

September 2010

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2011

Estimated (date passed)

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Phase 2Terminated

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Phase 2Completed

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Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device

Phase 2Completed

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Fish Oil and Aspirin With Type 2 Diabetes

Phase 2Completed

NCT02280655

Adverse Effects of Red Blood Cell Transfusions: A Unifying Hypothesis (Aim 3)

Phase 2Completed

NCT01357850

A Multi-center, Placebo-controlled Study to Evaluate the Safety of GSK716155 and Its Effects on Myocardial Metabolism, Myocardial Function, and Exercise Capacity in Patients With NYHA Class II/III Congestive Heart Failure

Phase 2Completed

Subjects who have attempted "best" cardiac medical therapy including long-acting nitrates, maximal use of beta-adrenergic blocking agents, and angiotensin-converting enzyme inhibitors without control of symptoms.

Subjects must be identified as non-candidates for conventional revascularization by their referring cardiologist. The patient's angiogram will then be reviewed by an independent interventional cardiologist and independent cardiac surgeon to determine if the patient is eligible for revascularization.

Subjects must have left ventricular ejection fraction \<40% by echocardiography.

All subjects must have a recent coronary angiogram (within the last 1 year) to document the coronary anatomy and insure the presence of coronary disease that is not amenable to standard revascularization procedures.

Have serum B-type Natriuretic Peptide (BNP) level \>100 pg/ml.

You may not qualify if:

Myocardial infarction (Q wave or non-Q wave defined as CKMB \>3 times normal) within 30 days of treatment.
Successful coronary revascularization procedures within 3 months of study enrollment.
Documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment.
NYHA Class I, II or IV heart failure and patients with idiopathic or non-ischemic heart failure.
History of severe aortic stenosis (aortic valve area \< 1.0 cm2) or insufficiency (\>2+); severe mitral stenosis (mitral valve area \<1.5 cm2); or severe mitral insufficiency(\>2+).
Implantation of biventricular pacemaker within 90 days of study treatment.
Severe co-morbidity associated with a reduction in life expectancy of less than 1 year, such as chronic medical illness (i.e. severe chronic obstructive pulmonary disease, renal failure or cancer).

Contact the study team to confirm eligibility.

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

Study Completion

September 2012

Estimated (date passed)

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

Last Updated

September 14, 2010

Record last verified: 2010-09

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: NCT00346177
Data provider: ClinicalTrials.gov
Source updated: 2010-09-14
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:37 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations