At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized, Double-blinded, Active-control and Unblinded Standard of Care (SOC) Controlled Study to Determine the Efficacy and Safety of Targeted Intramyocardial Delivery of Autologous CD34+ Cells (Auto-CD34+ Cells) for Increasing Exercise Capacity During Standardized Exercise Testing in Subjects With Refractory Angina Pectoris and Chronic Myocardial Ischemia
In Brief
A Phase 3 clinical trial evaluating Auto-CD34+ cells, Placebo: Diluent used to suspend Auto-CD34+ cells, and 1 other intervention for Chronic Myocardial Ischemia and 2 related conditions. Completed, enrolled 291 participants across 41 sites.
Detailed Summary
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 Details
Timeline
Interventions
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