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NCT03508609 · ClinicalTrials.gov registry record · Phase 2
Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease
A Phase 2 study of Coronary Microvascular Dysfunction, sponsored by Lisata Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT03508609: Completed Phase 2 study of Coronary Microvascular Dysfunction, sponsored by Lisata Therapeutics.
NCT03508609 is a Phase 2 study of Coronary Microvascular Dysfunction that has completed, run by Lisata Therapeutics. The registered enrollment target is 20 participants, below the 269-participant average among 7 other Coronary Microvascular Dysfunction trials with a reported enrollment target (93% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03508609, a Phase 2 study of Coronary Microvascular Dysfunction, has completed, sponsored by Lisata Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Coronary Flow Reserve (CFR) is a measure of coronary microvascular function.
Conditions Studied
Interventions
- BIOLOGICAL CLBS16
Study Locations (2)
California
- Cedars-Sinai Medical Center - Los Angeles
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-04-19 |
| Est. Completion | 2020-05-05 |
| Phase | Phase 2 |
What the finished NCT03508609 record still lists
NCT03508609 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 269-participant average among 7 other Coronary Microvascular Dysfunction trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Coronary Microvascular Dysfunction appearing as the primary indexed condition, and to 1 intervention - of which CLBS16 is the first listed.
NCT03508609 reports a single indexed study location in California, Minnesota.
Frequently Asked Questions
What is clinical trial NCT03508609 about?
NCT03508609 is a clinical study titled "Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease". 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.
What is the current status of trial NCT03508609?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2018-04-19. Estimated completion is 2020-05-05.
What conditions does trial NCT03508609 study?
This clinical trial studies the following conditions: Coronary Microvascular Dysfunction.
What interventions are being tested in trial NCT03508609?
The interventions under investigation include: CLBS16 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03508609?
This trial is sponsored by Lisata Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03508609 being conducted?
This trial has 2 study locations across California, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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