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Stem Cell Study for Patients With Heart Failure

Primary Purpose

Myocardial Ischemia, Congestive Heart Failure, Cardiovascular Disease

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Autologous Stem Cells
Sponsored by
Losordo, Douglas, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Ischemia focused on measuring heart, stem Cells, low EF, heart attack, cardiomyopathy, congestive heart failure, cardiovascular disease, Heart Failure, Low Ejection Fraction

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Stem Cells

Placebo

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
June 27, 2006
Last Updated
September 10, 2010
Sponsor
Losordo, Douglas, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT00346177
Brief Title
Stem Cell Study for Patients With Heart Failure
Official Title
Injection of Autologous CD34+ Cells for Neovascularization and Symptom Relief in Patients With Myocardial Ischemia and LVEF < 40%
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Withdrawn
Why Stopped
Funding not obtained. No subjects enrolled.
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
September 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Losordo, Douglas, M.D.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Stem Cells
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Biological
Intervention Name(s)
Autologous Stem Cells
Intervention Description
Intramyocardial injections
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas W. Losordo, M.D.
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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Stem Cell Study for Patients With Heart Failure

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