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

Coronary Microvascular Disease Clinical Trial

— FREEDOM  

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04614467
• Other study ID #: CLBS16-P02
• Status: Terminated
• Phase: Phase 2
• Start date: October 29, 2020
• Est. completion date: September 28, 2022

Study information

• Verified date: October 2023
• Source: Lisata Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Microvascular Disease
• Coronary Microvascular Dysfunction
• Microvascular Angina
• Microvascular Coronary Artery Disease
• Myocardial Ischemia

Intervention

Biological:
• CLBS16
GCSF-mobilized autologous CD34+ cells
• Placebo
isotonic solution (no CD34+ cells)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Lisata Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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