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Stem Cell Study for Patients With Heart Failure
This study is not yet open for participant recruitment.
Verified by Losordo, Douglas, M.D., August 2008
Sponsored by: Losordo, Douglas, M.D.
Information provided by: Losordo, Douglas, M.D.
ClinicalTrials.gov Identifier: NCT00346177
  Purpose

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: Autologous Stem Cells
Phase I

MedlinePlus related topics: Heart Failure
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Injection of Autologous CD34+ Cells for Neovascularization and Symptom Relief in Patients With Myocardial Ischemia and LVEF < 40%

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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: January 2009
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Stem Cells
Biological: Autologous Stem Cells
Intramyocardial injections
2: Active Comparator
Stem Cells
Biological: Autologous Stem Cells
Intramyocardial injections
3: Placebo Comparator
Placebo
Biological: Autologous Stem Cells
Intramyocardial injections

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects greater than 21 years old.
  • 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 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 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346177

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

Responsible Party: Northwestern University/Northwestern Memorial Hospital ( Director, Feinberg Cardiovascular Research Institute, Program in Cardiovascular Regenerative Medicine )
Study ID Numbers: BB-IND-11196-02
Study First Received: June 27, 2006
Last Updated: August 19, 2008
ClinicalTrials.gov Identifier: NCT00346177  
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Heart Failure
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Neovascularization, Pathologic
Ischemia
Cardiomyopathies
Myocardial Infarction

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009