Phase
Condition
Coronary Artery Disease
Atherosclerosis
Chest Pain
Treatment
N/AClinical Study ID
Ages 21-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Main Inclusion Criteria:
Male or female participants who are 21 to 80 years of age at the time of signing theinformed consent.
Participants with Canadian Cardiovascular Society (CCS) class III or IV chronicrefractory angina.
Participants without control of their angina symptoms in spite of maximal tolerateddoses of anti-angina drugs. Participants must be on optimal therapy for their anginaand must have been on a stable anti-anginal medication regimen for at least 4 weeksbefore signing the informed consent form.
Participants with obstructive coronary disease unsuitable for conventionalrevascularization due to unsuitable anatomy or comorbidity as determined at the siteand confirmed by an independent adjudication committee.
Participants must have evidence of inducible myocardial ischemia.
Participants must experience angina episodes.
Participants must be able to complete 2 exercise tolerance tests on the treadmillwithin 3 weeks of randomization.
If female of childbearing potential, subject must not be pregnant and agree to employadequate birth control measures for the duration of the study.
Exclusion
Main Exclusion Criteria:
Cardiovascular hospitalization within 60 days prior to potential study enrollment.Participant has had a successful or partially successful coronary artery bypass graft (CABG) within 6 months or PCTA within 60 days of potential study enrollment.
Participant has had a placement of a bi-ventricular pacemaker for cardiacresynchronization therapy (CRT) for heart failure within 180 days of potential studyenrollment.
Participant has documented stroke or transient ischemic attacks (TIAs) within 60 daysof potential study enrollment.
Participant has a history of moderate to severe aortic stenosis; or severe aorticinsufficiency; or severe mitral stenosis; or severe mitral insufficiency.
Participant has a prosthetic aortic valve or a mechanical mitral valve replacement.
Participant has severe co-morbidity associated with a reduction in life expectancy toless than 3 years as a result of chronic medical illnesses.
Participants with cancer are excluded with the following exceptions:
Subjects with in-situ non-melanoma skin cancer or in-situ cervical cancer are notexcluded.
Participants that have been cancer free for >= 5 years as determined by theironcologist are not excluded. Subjects with a prior history of stem celltransplant for cancer are excluded no matter how long they have been cancer-free.
Participants with a history of leukemia or other bone marrow disease.
Participant has sickle cell disease or sickle cell trait.
Participants with proliferative retinopathy.
Participants with Hb A1c > 9%.
Participant has platelet counts >10% above the upper limit of normal (ULN) or plateletcounts < 70,000.
Participant has a hematocrit < 30% prior to potential study enrollment.
Participant has a serum creatinine > 2.5 mg/dL prior to potential study enrollment.
Participant tests positive for HIV, hepatitis B, or hepatitis C, or is on chronicimmunosuppressive medications, or has had a previous stem cell transplant.
Participant has a known contraindication to Neupogen (filgrastim) or G-CSF.
Participant was previously enrolled in an active treatment group of cell therapytrials for cardiovascular disease including any phase of CD34+ stem cell trials.
Left ventricular (LV) thickness of < 7 mm in the target areas of injection as measuredby during a 2-D echocardiogram (ECHO).
Atrial fibrillation, atrial flutter, or other uncontrolled arrhythmias that wouldprohibit accurate electromechanical mapping and NOGA-guided intramyocardial injection.
Bleeding diathesis with an INR > 1.8 when not receiving anti-thrombotic therapy.
Hepatic dysfunction as evidenced by elevated AST or ALT levels > 2.5 x ULN.
Any previous transplant requiring immunosuppression.
Disease state requiring chronic immunosuppression.
Study Design
Connect with a study center
London Health Sciences Centre
London, Ontario N6A 5A5
CanadaSite Not Available
St. Michael´s Hospital
Toronto, Ontario M5B 1W8
CanadaSite Not Available
Montreal Heart Institute
Montreal, Quebec H1T 1C8
CanadaSite Not Available
Birmingham, Alabama
United StatesSite Not Available
Gilbert, Arizona
United StatesSite Not Available
Phoenix, Arizona
United StatesSite Not Available
La Jolla, California
United StatesSite Not Available
Los Angeles, California
United StatesSite Not Available
Oxnard, California
United StatesSite Not Available
San Diego, California
United StatesSite Not Available
Stanford, California
United StatesSite Not Available
Boynton Beach, Florida
United StatesSite Not Available
Daytona Beach, Florida
United StatesSite Not Available
Gainesville, Florida
United StatesSite Not Available
Jacksonville, Florida
United StatesSite Not Available
Miami, Florida
United StatesSite Not Available
Orlando, Florida
United StatesSite Not Available
Tampa, Florida
United StatesSite Not Available
Atlanta, Georgia
United StatesSite Not Available
Augusta, Georgia
United StatesSite Not Available
Chicago, Illinois
United StatesSite Not Available
Iowa City, Iowa
United StatesSite Not Available
Louisville, Kentucky
United StatesSite Not Available
New Orleans, Louisiana
United StatesSite Not Available
Boston, Massachusetts
United StatesSite Not Available
Saginaw, Michigan
United StatesSite Not Available
Minneapolis, Minnesota
United StatesSite Not Available
Rochester, Minnesota
United StatesSite Not Available
Haddon Heights, New Jersey
United StatesSite Not Available
Newark, New Jersey
United StatesSite Not Available
University of Buffalo
Buffalo, New York 14214
United StatesSite Not Available
New York, New York
United StatesSite Not Available
Charlotte, North Carolina
United StatesSite Not Available
Durham, North Carolina
United StatesSite Not Available
Cincinnati, Ohio
United StatesSite Not Available
Cleveland, Ohio
United StatesSite Not Available
Philadelphia, Pennsylvania
United StatesSite Not Available
Pittsburgh, Pennsylvania
United StatesSite Not Available
Germantown, Tennessee
United StatesSite Not Available
Dallas, Texas
United StatesSite Not Available
Houston, Texas
United StatesSite Not Available
Salt Lake City, Utah
United StatesSite Not Available
Seattle, Washington
United StatesSite Not Available
Madison, Wisconsin
United StatesSite Not Available
Milwaukee, Wisconsin
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.