The purpose of the study is to assess the safety and efficacy of targeted intramyocardial delivery of Auto-CD34+ cells for increasing exercise time and amelioration of anginal symptoms in subjects with refractory angina and chronic myocardial ischemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
291
10 intramyocardial injections of 0.2 mL per injection site of Auto-CD34+ cells
10 intramyocardial injections of 0.2 mL per injection site of placebo
Standard of care for refractory angina
Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) Using the Modified Bruce Protocol
Baseline (BL) is the average of the two total exercise times measured during the screening period.
Time frame: Baseline and 12 month visit
Angina Frequency (Episodes Per Week) at the 12 Month Follow-up Visit
Participants self-reported angina episodes utilizing an electronic diary for 4 weeks at baseline (screening period) and in the 4 weeks before the 3, 6 and 12 month follow-up visits.
Time frame: Baseline and 12 month visit
Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) at the 6 Month Follow-up Visit
Baseline (BL) is the average of the two total exercise times measured during the screening period.
Time frame: Baseline and 6 month visit
Angina Frequency (Episodes Per Week) at the 6 Month Follow-up Visit
Time frame: 6 month visit
Percentage of Participants With Incidences of MACE From Randomization Until the End of the 24 Month Follow-up Period
Major adverse cardiac events (MACE) defined as death, cardiac hospitalization, non-fatal myocardial infarction and stroke, as adjudicated by an independent clinical endpoint classification (CEC) committee. The category Total MACE includes death, cardiovascular hospitalization, myocardial infarction or stroke.
Time frame: From randomization until the end of the 24 month follow-up period
Percentage of Participants With at Least One Serious Adverse Event (SAE) From Randomization Until the End of the 24 Month Follow-up Period
Time frame: From randomization until the end of the 24 month follow-up period
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Birmingham, Alabama, United States
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Gilbert, Arizona, United States
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Phoenix, Arizona, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Oxnard, California, United States
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San Diego, California, United States
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Stanford, California, United States
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Boynton Beach, Florida, United States
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Daytona Beach, Florida, United States
...and 31 more locations