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

Phase 2

Terminated

• Conditions: Coronary Microvascular Disease; Microvascular Coronary Artery Disease; Coronary Microvascular Dysfunction
• Interventions: Biological: Placebo; Biological: CLBS16

• Registration Number: NCT04614467
• Lead Sponsor: Lisata Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-29
• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-10-29
• Study First Posted: 2020-11-04
• Primary Completion: 2022-09-28
• Study Completion: 2022-09-28
• Status Verified: 2023-10
• Disposition First Submitted: 2023-10-02
• Disposition First Posted: 2023-10-06
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
GCSF-mobilized autologous CD34+ cells	CLBS16	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

University of Florida - College of Medicine/ div of Cardiovascular Medicine; 🇺🇸 Gainesville, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

The Christ Hospital; 🇺🇸 Cincinnati, Ohio, 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

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States