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 Number of Angina Attacks Per Week
Time frame: Baseline to Month 3
Change From Baseline in CCS Angina Class
This measure assesses the change in the Canadian Cardiovascular Society angina class scale. CCS angina class was assessed at baseline and again at 3 months and reported as the mean difference. CCS classes are as follows (negative change indicates an improvement): Class 0: No angina with ordinary activity Class I: Angina only with strenuous, prolonged, or rapid exertion Class II: Angina with slight limitations of ordinary activity (e.g., walking uphill, climbing stairs) Class III: Angina with marked limitations of ordinary activity (e.g., walking one to two blocks, climbing one flight of stairs) Class IV: Angina at rest or with minimal exertion
Time frame: Baseline to 3 months
Change From Baseline in Total Exercise Time
Time frame: Baseline to 6 months
Change From Baseline in Health-related Quality of Life (HRQoL)
Seattle Angina Questionnaire (SAQ) Scoring is 0 to 100 with higher numbers better
Time frame: Baseline to 3 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