Renew

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

Renew [NCT01508910]

Description: 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

Biological: Auto-CD34+ cells; Placebo: Diluent; Other: Standard of care

Primary Investigator: Kereiakes

Drug/Device Information
Intramyocardial delivery of G-CSF mobilized autologous CD34+ CELLS vs placebo
The investigational product (IP) consists of 1 x 105 cells (±20%) /kg, up to a maximal dose of 1 x 107 cells
Mobilized autologous CD34+ cells will be collected via apheresis
Baxter Healthcare Corporation
Major Inclusion and Exclusion
≤ 80 with Canadian Cardiovascular Society Angina class III or IV (chronic refractory angina)
Must be taking an antiplatlet and a statin (unless intolerance documented)
Must be taking at least 2 anti-anginal medications at maximum tolerated doses
Must have objective evidence of inducible ischemia in the potential injection target zone