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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Coronary Microvascular Dysfunction, Coronary Microvascular Disease, Microvascular Coronary Artery Disease

Intervention / Treatment
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* Biological: CLBS16
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GCSF-mobilized autologous CD34+ cells<br> | Biological: CLBS16<br>* GCSF-mobilized autologous CD34+ cells<br>|
| Placebo Comparator: Placebo<br> | Biological: Placebo<br>* isotonic solution (no CD34+ cells)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in angina frequency |  | Baseline to 3 and 6 months | 
| Change from baseline in CCS angina class |  | Baseline to 3 and 6 months | 
| Change from baseline in total exercise time |  | Baseline to 6 months | 
| Change from baseline in health-related quality of life (HRQoL) |  | Baseline to 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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angina, CMD, MVD, non-obstructive coronary artery disease