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

Lisata Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Coronary Microvascular Disease; Coronary Microvascular Dysfunction; Microvascular Coronary Artery Disease

Treatments: Biological: Placebo; Biological: CLBS16

Study type: Interventional

Funder types: Industry

Identifiers

NCT04614467

CLBS16-P02

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 2 patient groups, including a placebo group

GCSF-mobilized autologous CD34+ cells

Experimental group

Treatment:

Biological: CLBS16

Placebo

Placebo Comparator group

Treatment:

Biological: Placebo