NCT00346177

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2006

Completed
4.2 years until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

September 14, 2010

Status Verified

September 1, 2010

Enrollment Period

1 year

First QC Date

June 27, 2006

Last Update Submit

September 10, 2010

Conditions

Myocardial IschemiaCongestive Heart FailureCardiovascular Disease

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

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.
  • 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.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

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 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2012

Last Updated

September 14, 2010

Record last verified: 2010-09

Locations

US(1)