Coronary Microvascular Disease Clinical Trial
— FREEDOMOfficial title:
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
Verified date | October 2023 |
Source | Lisata Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 34 |
Est. completion date | September 28, 2022 |
Est. primary completion date | September 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Emory University Hospital | Atlanta | Georgia |
United States | The Christ Hospital | Cincinnati | Ohio |
United States | University of Florida - College of Medicine/ div of Cardiovascular Medicine | Gainesville | Florida |
United States | Memorial Regional Hospital | Hollywood | Florida |
United States | Cedars-Sinai Medical Center | Los Angeles | California |
United States | Minneapolis Heart Institute at Abbott Northwestern Hospital | Minneapolis | Minnesota |
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Lisata Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in angina frequency | Baseline to 3 and 6 months | ||
Primary | Change from baseline in CCS angina class | Baseline to 3 and 6 months | ||
Primary | Change from baseline in total exercise time | Baseline to 6 months | ||
Primary | Change from baseline in health-related quality of life (HRQoL) | Baseline to 3 and 6 months |
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