Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease

An Open-Label Exploratory Clinical Study to Evaluate the Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction (CMD) and Without Obstructive Coronary Artery Disease

This clinical trial will explore the safety and effect of GCSF-mobilized autologous ex vivo selected 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 intracoronary infusion of CLBS16.

Inclusion Criteria:

• Men or women age ≥18
• History of and currently experiencing angina at least 3 times per week
• No obstructive coronary artery disease
• On stable medical therapy for 30 days prior to enrollment
• Must agree to use a reliable and acceptable method of contraception for the duration of participation
• Written informed consent

Exclusion Criteria:

• Myocardial infarction within 90 days
• Prior evidence of obstructive heart disease including PCI or CABG (or planned PCI or CABG)
• Diagnosis of other specific cardiac disease
• Must meet LVEF and GFR requirements
• Current use of coumadin or DOACs
• Hypersensitivity to G-CSF, apheresis or study product components
• Positive for HIV, hepatitis B or hepatitis C
• Active inflammatory or autoimmune disease, or chronic immunosuppressive state
• Drug abuse
• Pregnant or lactating
• Malignant neoplasm within 5 years
• History of Sickle Cell Disease
• Participation in another clinical study within 90 days