A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular Dysfunction

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Coronary Microvascular Dysfunction, Coronary Microvascular Disease, Microvascular Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT04614467

Run by

Lisata Therapeutics, Inc.

People needed

34

Starts

2020-10-29

Expected to finish

2022-09-28

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of Florida - College of Medicine/ div of Cardiovascular Medicine — Gainesville, Florida, United States
• Memorial Regional Hospital — Hollywood, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Minneapolis Heart Institute at Abbott Northwestern Hospital — Minneapolis, Minnesota, United States
• Mayo Clinic in Rochester — Rochester, Minnesota, United States
• The Christ Hospital — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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