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Stem Cell Study for Subjects With Congestive Heart Failure

This study has been terminated.
(Study terminated due to lack of funding.)
Information provided by (Responsible Party):
Losordo, Douglas, M.D. Identifier:
First received: February 7, 2008
Last updated: March 30, 2015
Last verified: November 2011
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.

Condition Intervention Phase
Myocardial Ischemia
Congestive Heart Failure
Cardiovascular Disease
Biological: Intramyocardial injection of autologous CD34-positive cells (stem cells)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Injection of Autologous CD34+ Cells for Neovascularization and Symptom Relief in Patients With Myocardial Ischemia and LVEF < 40%

Resource links provided by NLM:

Further study details as provided by Losordo, Douglas, M.D.:

Primary Outcome Measures:
  • Safety of intramyocardial administration of CD34-positive cells [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Effects of intramyocardial injections of autologous CD34-positive cells on clinical outcomes. [ Time Frame: 6 months ]
    Clinical outcomes assessed include symptoms, change in health status, myocardial function and exercise duration.

Enrollment: 4
Study Start Date: March 2008
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose of autologous CD34-positive cells (stem cells) Biological: Intramyocardial injection of autologous CD34-positive cells (stem cells)
Comparison between a low dose and high dose of autologous (one's own) CD34-positive cells (stem cells) delivered via injections into the heart muscle.
Experimental: High dose of autologous CD34-positive cells (stem cells) Biological: Intramyocardial injection of autologous CD34-positive cells (stem cells)
Comparison between a low dose and high dose of autologous (one's own) CD34-positive cells (stem cells) delivered via injections into the heart muscle.


Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects 21 to 80 years old (inclusive).
  • Subjects with functional class (NYHA) II or 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 (ACE)inhibitors without control of symptoms.
  • Subjects must be identified as non-candidates for conventional revascularization by their referring cardiologist.
  • Subjects must have left ventricular ejection fraction <40% by echocardiography.
  • All subjects must have a recent coronary angiogram (within the last 6 months) 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:

  • 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 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).
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Please refer to this study by its identifier: NCT00620048

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Losordo, Douglas, M.D.
Principal Investigator: Douglas W. Losordo, M.D. Northwestern University
  More Information

Responsible Party: Losordo, Douglas, M.D. Identifier: NCT00620048     History of Changes
Other Study ID Numbers: STU00002516
11196-03 ( Other Identifier: Sponsor protocol number )
Study First Received: February 7, 2008
Last Updated: March 30, 2015

Keywords provided by Losordo, Douglas, M.D.:
stem Cells
low EF
heart attack
congestive heart failure
cardiovascular disease
Heart Failure
Low Ejection Fraction

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Myocardial Ischemia
Coronary Artery Disease
Heart Diseases
Pathologic Processes
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases processed this record on May 25, 2017