This clinical trial will explore the efficacy and safety of GCSF-mobilized autologous CD34+ cells for the treatment of CMD in adults currently experiencing angina and with no obstructive coronary artery disease. Eligible subjects will receive a single administration of CLBS16 or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
34
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of Florida - College of Medicine/ div of Cardiovascular Medicine
Gainesville, Florida, United States
Memorial Regional Hospital
Hollywood, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Change from baseline in angina frequency
Time frame: Baseline to 3 and 6 months
Change from baseline in CCS angina class
Time frame: Baseline to 3 and 6 months
Change from baseline in total exercise time
Time frame: Baseline to 6 months
Change from baseline in health-related quality of life (HRQoL)
Time frame: Baseline to 3 and 6 months
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Minneapolis Heart Institute at Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
The Christ Hospital
Cincinnati, Ohio, United States