An Open-Label Exploratory Clinical Study to Evaluate the Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction (CMD) and Without Obstructive Coronary Artery Disease

Lisata Therapeutics, Inc.2 sites in 1 country20 target enrollmentApril 19, 2018

ConditionsCoronary Microvascular Dysfunction

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Coronary Microvascular Dysfunction
Sponsor: Lisata Therapeutics, Inc.
Enrollment: 20
Locations: 2
Primary Endpoint: Change From Baseline in Coronary Flow Reserve
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This clinical trial will explore the safety and effect of GCSF-mobilized autologous ex vivo selected 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 intracoronary infusion of CLBS16.

Registry

clinicaltrials.gov

Start Date

April 19, 2018

End Date

May 5, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Lisata Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Men or women age ≥18
•History of and currently experiencing angina at least 3 times per week
•No obstructive coronary artery disease
•On stable medical therapy for 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 G-CSF, 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

Outcomes

Primary Outcomes

Change From Baseline in Coronary Flow Reserve

Time Frame: Day 180

Coronary Flow Reserve (CFR) is a measure of coronary microvascular function.

Secondary Outcomes

Change From Baseline in Peripheral Arterial Tonometry(Day 180)
Change From Baseline in Microvascular Function as Assessed by Intracoronary Administration of Acetylcholine(Day 180)
Change in Angina Frequency From Baseline(6 months)
Change From Baseline in Seattle Angina Questionnaire(6 months)
Change From Baseline in SF-36 Scores(6 months)
Canadian Cardiovascular Society Angina Class(6 months)