ACT34-CMI -- Adult Autologous CD34+ Stem Cells
The purpose of this study is to evaluate the efficacy and safety of intramyocardial injections of adult stem cells in patients with refractory chronic myocardial ischemia.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Double-blind, Prospective, Randomized, Placebo-controlled Study to Determine the Tolerability, Efficacy, Safety, and Dose Range of Intramyocardial Injections of G-CSF Mobilized Auto--CD34+ Cells for Reduction of Angina Episodes in Patients With Refractory Chronic Myocardial Ischemia (ACT34-CMI)|
- Frequency of angina episodes [ Time Frame: 6 months after treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2006|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
This is a double-blind, prospective, randomized, placebo-controlled trial to determine the tolerability, efficacy, safety and dose range of intramyocardial injections of adult autologous CD34+ cells mobilized with granulocyte colony stimulating factor for the reduction of angina episodes in patients with refractory chronic myocardial ischemia.
Show 26 Study Locations
|Study Director:||Baxter Healthcare Corporation||One Baxter Parkway, Deerfield, IL 60015|