Safety and Potential Bioactivity of CLBS14 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 CLBS14 in Patients With Coronary Microvascular Dysfunction (CMD) and Without Obstructive Coronary Artery Disease
Doctors at Cedars-Sinai Medical Center in CA and the Mayo Clinic in MN seek patients with coronary microvascular dysfunction and without obstructive coronary artery disease. The treatment selects particular immune T-cells that are have innate ability to repair small blood vessels for microcirculation, multiplies them outside the body, then re-administers them to the patient. In addition, an immune-stimulating medicine (GCSF) will be administered prior to the collection of stem cells to increase their numbers.
After GCSF medication, study participants will undergo a blood draw treatment that sorts out specific stem cells and returns the blood to the patient. After the cells are multiplied and re-infused, follow-up will last at least a year.
- Be 18 years of age or older
- Have no obstructive coronary artery disease
- Not be pregnant or lactating
THE STUDY INVOLVES:
- Screening before the treatment
- Following GCSF medication, leukapheresis will draw the needed immune cells but return blood cells to the body.
- The gene-modified immune cells will be re-infused to the patient.
- The patient will be closely assessed during treatment, with follow-up for 1 year.
LOCATIONS AND CONTACTS:
Trials will take place at the Cedars-Sinai Medical Center in Los Angeles, CA, Map, and
Mayo Clinic in Rochester in Rochester, MN, Map.
Chrissy Kotynski | (908) 842-0093 | [email protected]
Scott Volk | (949) 346-8784 | [email protected]
Caladrius Biosciences, Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Cedars-Sinai Medical Center
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