Safety and Potential Bioactivity of CLBS14 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/1/2019
Start Date:April 19, 2018
End Date:April 2020
Contact:Chrissy Kotynski
Email:ckotynski@caladrius.com
Phone:(908) 842-0093

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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

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 CLBS14.


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
We found this trial at
2
sites
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Timothy Henry, MD
Phone: 310-423-9666
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: Amir Lerman, MD
Phone: 507-255-6884
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Rochester, MN
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