CClinicalTrials.gg
WithdrawnNCT00346177Updated Sep 14, 2010

Stem Cell Study for Patients With Heart Failure

A Phase 2 interventional study of Autologous Stem Cells in Myocardial Ischemia, Congestive Heart Failure and Cardiovascular Disease, sponsored by Losordo, Douglas, M.D.. Withdrawn at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2010-09-14.

Sponsored by Losordo, Douglas, M.D. · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Funding not obtained. No subjects enrolled.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Myocardial Ischemia
  • Congestive Heart Failure
  • Cardiovascular Disease

Keywords

  • heart
  • stem Cells
  • low EF
  • heart attack
  • cardiomyopathy
  • congestive heart failure
  • cardiovascular disease
  • Heart Failure
  • Low Ejection Fraction
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 30 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Losordo, Douglas, M.D. is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    1

    Stem Cells

    Biological: Autologous Stem Cells

  • Placebo comparator
    2

    Placebo

    Biological: Autologous Stem Cells

Interventions

  • BiologicalAutologous Stem Cells

    Intramyocardial injections

06

What researchers measure

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.

    Time frame: 6 months

07

Study locations

1 site
  • Northwestern University
    Chicago, Illinois 60611, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00346177
Lead sponsor
Losordo, Douglas, M.D.
First posted
Jun 29, 2006
Start date
Sep 2010
Primary completion
Sep 2011 (estimated)
Completion
Sep 2012 (estimated)
Last update
Sep 14, 2010

Study contacts

Douglas W. Losordo, M.D.
principal investigator · Northwestern University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion