Stem Cell Study for Patients With Heart Failure
This study has been withdrawn prior to enrollment.
(Funding not obtained. No subjects enrolled.)
Sponsor:
Losordo, Douglas, M.D.
Information provided by:
Losordo, Douglas, M.D.
ClinicalTrials.gov Identifier:
NCT00346177
First received: June 27, 2006
Last updated: September 10, 2010
Last verified: September 2010
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) 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:
- 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: | 30 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Stem Cells
|
Biological: Autologous Stem Cells
Intramyocardial injections
|
|
Placebo Comparator: 2
Placebo
|
Biological: Autologous Stem Cells
Intramyocardial injections
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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:
- 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).
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
No publications provided
| Responsible Party: | Director, Feinberg Cardiovascular Research Institute, Program in Cardiovascular Regenerative Medicine, Northwestern University/Northwestern Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT00346177 History of Changes |
| Other Study ID Numbers: | BB-IND-11196-02 |
| Study First Received: | June 27, 2006 |
| Last Updated: | September 10, 2010 |
| 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:
|
Cardiovascular Diseases Myocardial Ischemia Coronary Artery Disease Heart Failure Ischemia Heart Diseases |
Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013