Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction an… (NCT03508609) | Clinical Trial Compass
CompletedPhase 2
Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease
United States20 participantsStarted 2018-04-19
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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