A Double-Blind, Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of CLBS16 in Subjects With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease

CLBS16-P02

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.

2020-10-29

2022-09-28

2022-09-28

Terminated

Early phase I

34

Inclusion Criteria: * Men or women age ≥18 * History of and currently experiencing angina at least 3 times per week * Prior diagnosis of CMD based on coronary flow reserve (CFR) ≤ 2.5 or other measures * Canadian Cardiovascular Society (CCS) class II, III or IV chronic refractory angina * No obstructive coronary artery disease * On stable medical therapy for at least 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 GCSF, 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 prior to informed consent or concurrently with this study * Previous treatment with a CD34+ cell based therapy

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 34, 'type': 'ACTUAL'}}

2023-10-17