Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease

Lisata Therapeutics

Status and phase

Completed

Phase 2

Conditions

Coronary Microvascular Dysfunction

Treatments

Biological: CLBS16

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT03508609

1R44HL135889-01 (U.S. NIH Grant/Contract)

CLBS16-P01

Details and patient eligibility

About

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.

Enrollment

20 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
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
Malignant neoplasm within 5 years
History of Sickle Cell Disease
Participation in another clinical study within 90 days