Stem Cell Study for Subjects With Congestive Heart Failure

Cardiovascular Disease Clinical Trial

Official title:

Injection of Autologous CD34+ Cells for Neovascularization and Symptom Relief in Patients With Myocardial Ischemia and LVEF < 40%

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00620048
• Other study ID #: STU00002516
• Secondary ID: 11196-03
• Status: Terminated
• Phase: Phase 1
• First received: February 7, 2008
• Last updated: March 30, 2015
• Start date: March 2008

Study information

• Verified date: November 2011
• Source: Losordo, Douglas, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Congestive Heart Failure
• Coronary Artery Disease
• Heart Failure
• Ischemia
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Losordo, Douglas, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of intramyocardial administration of CD34-positive cells		6 months	Yes
Secondary	Effects of intramyocardial injections of autologous CD34-positive cells on clinical outcomes.	Clinical outcomes assessed include symptoms, change in health status, myocardial function and exercise duration.	6 months	No