Phase 2 N=20 Treatment

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

Coronary Microvascular Dysfunction

Bottom Line

View on ClinicalTrials.gov: NCT03508609 ↗

Enrolled (actual)

Serious AEs

30.0%

Results posted

Jan 2021

Primary outcome: Primary: Change From Baseline in Coronary Flow Reserve — 0.62 ratio

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: CLBS16 (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Lisata Therapeutics, Inc.
Primary completion: Dec 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Coronary Flow Reserve	0.62	—
SECONDARY Change From Baseline in Microvascular Function as Assessed by Intracoronary Administration of Acetylcholine	9.4	—
SECONDARY Change From Baseline in Peripheral Arterial Tonometry	-0.19	—
SECONDARY Change in Angina Frequency From Baseline	-2.34	—
SECONDARY Canadian Cardiovascular Society Angina Class	-1.21	—
SECONDARY Change From Baseline in Seattle Angina Questionnaire	16.81; 23.61; 18.33; 12.83; 23.68	—
SECONDARY Change From Baseline in SF-36 Scores	6.66; 5.62; 5.94; 9.81; 5.50; 3.53	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03508609). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.