Phase 2
Completed N=20
Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease
Coronary Microvascular Dysfunction
Source: ClinicalTrials.gov NCT03508609 ↗
Enrolled (actual)
20
Serious AEs
30.0%
Results posted
Jan 2021
Primary outcomePrimary: Change From Baseline in Coronary Flow Reserve — 0.62 ratio
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.
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 | — |
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
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. Informational only — not medical advice.