Coronary Microvascular Disease, Coronary Microvascular Dysfunction, Microvascular Coronary Artery Disease
Conditions
Keywords
angina, CMD, MVD, non-obstructive coronary artery disease
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.
Interventions
BIOLOGICALCLBS16
GCSF-mobilized autologous CD34+ cells
BIOLOGICALPlacebo
isotonic solution (no CD34+ cells)
Sponsors
Lisata Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Number of Angina Attacks Per Week | Baseline to Month 3 | — |
| Change From Baseline in CCS Angina Class | Baseline to 3 months | This measure assesses the change in the Canadian Cardiovascular Society angina class scale. CCS angina class was assessed at baseline and again at 3 months and reported as the mean difference. CCS classes are as follows (negative change indicates an improvement): Class 0: No angina with ordinary activity Class I: Angina only with strenuous, prolonged, or rapid exertion Class II: Angina with slight limitations of ordinary activity (e.g., walking uphill, climbing stairs) Class III: Angina with marked limitations of ordinary activity (e.g., walking one to two blocks, climbing one flight of stairs) Class IV: Angina at rest or with minimal exertion |
| Change From Baseline in Total Exercise Time | Baseline to 6 months | — |
| Change From Baseline in Health-related Quality of Life (HRQoL) | Baseline to 3 months | Seattle Angina Questionnaire (SAQ) Scoring is 0 to 100 with higher numbers better |
Countries
United States
Contacts
STUDY_DIRECTORKristen K Buck, MD
Lisata Therapeutics, Inc.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 57.9 years STANDARD_DEVIATION 8.01 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Region of Enrollment United States | 32 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 14 |
| other Total, other adverse events | 20 / 20 | 14 / 14 |
| serious Total, serious adverse events | 7 / 20 | 2 / 14 |
Outcome results
None listed