Stem Cell Study for Subjects With Congestive Heart Failure

This study has been terminated.
(Study terminated due to lack of funding.)
Sponsor:
Information provided by (Responsible Party):
Losordo, Douglas, M.D.
ClinicalTrials.gov Identifier:
NCT00620048
First received: February 7, 2008
Last updated: November 7, 2011
Last verified: November 2011
  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: Intramyocardial injection of autologous CD34-positive cells (stem cells)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effects of intramyocardial injections of autologous CD34-positive cells on clinical outcomes. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Clinical outcomes assessed include symptoms, change in health status, myocardial function and exercise duration.


Enrollment: 4
Study Start Date: March 2008
Estimated Study Completion Date: December 2011
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.

  Eligibility

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

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620048

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

No publications provided

Responsible Party: Losordo, Douglas, M.D.
ClinicalTrials.gov Identifier: NCT00620048     History of Changes
Other Study ID Numbers: STU00002516, 11196-03
Study First Received: February 7, 2008
Last Updated: November 7, 2011
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

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Ischemia
Myocardial Ischemia
Coronary Artery Disease
Heart Diseases
Pathologic Processes
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on October 19, 2014