Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease
Completed · Phase 2
Conditions studied: Coronary Microvascular Dysfunction
In brief
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.
Key facts
- Study ID
- NCT03508609
- Run by
- Lisata Therapeutics, Inc.
- People needed
- 20
- Starts
- 2018-04-19
- Expected to finish
- 2020-05-05
- Last updated by the study team
- 2021-01-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- Mayo Clinic in Rochester — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.