Clinical trial NCT04614467: A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular Dysfunction
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Coronary Microvascular Dysfunction
Coronary Microvascular Disease
Microvascular Coronary Artery Disease
Keywords: angina
CMD
MVD
non-obstructive coronary artery disease
Lead sponsor: Lisata Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-04
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in angina frequency
timeFrame: Baseline to 3 and 6 months
measure: Change from baseline in CCS angina class
timeFrame: Baseline to 3 and 6 months
measure: Change from baseline in total exercise time
timeFrame: Baseline to 6 months
measure: Change from baseline in health-related quality of life (HRQoL)
timeFrame: Baseline to 3 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Gainesville
country: United States
facility: University of Florida - College of Medicine/ div of Cardiovascular Medicine
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute at Abbott Northwestern Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
Study officials:
affiliation: Lisata Therapeutics, Inc.
name: Kristen K Buck, MD
role: STUDY_DIRECTOR
References:
citation: Rai B, Shukla J, Henry TD, Quesada O. Angiogenic CD34 Stem Cell Therapy in Coronary Microvascular Repair-A Systematic Review. Cells. 2021 May 8;10(5):1137. doi: 10.3390/cells10051137.