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NCT05925608 · ClinicalTrials.gov registry record · Phase 1
Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells
A Phase 1 study of Heart Failure, Systolic, sponsored by BioCardia.
- Active
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
- 1
- Study location
NCT05925608: Active Phase 1 study of Heart Failure, Systolic, sponsored by BioCardia.
NCT05925608 is a Phase 1 study of Heart Failure, Systolic that is active but no longer recruiting, run by BioCardia. The registered enrollment target is 39 participants, below the 333-participant average among 13 other Heart Failure, Systolic trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05925608, a Phase 1 study of Heart Failure, Systolic, is active but no longer recruiting, sponsored by BioCardia.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
- 1
- Study location
Study Summary
This clinical study will utilize allogenic bone marrow-derived culture-expanded MSC that are expanded from mesenchymal stem cells and delivered using the investigational Helix transendocardial delivery catheter as a therapy for ischemic HFrEF with reduced ejection fraction.
Primary Outcome
Incidence of TE-SAE defined as a composite of death, non-fatal MI, stroke, worsening HF (requiring admission, iv diuretics and/or inotropics), myocardial perforation (with tamponade), ventricular arrythmias \>15 seconds
Conditions Studied
Interventions
- COMBINATION_PRODUCT CardiALLO™ Human Allogenic Culture-expanded Bone marrow-derived Mesenchymal Stem Cells (hMSCs)
- DIAGNOSTIC_TEST Diagnostic Catheterization
Study Locations (1)
Florida
- University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2023-08-23 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
What the registry record for NCT05925608 still lists
NCT05925608 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 333-participant average among 13 other Heart Failure, Systolic trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Heart Failure, Systolic appearing as the primary indexed condition, and to 2 interventions - of which CardiALLO™ Human Allogenic Culture-expanded Bone marrow-derived Mesenchymal Stem Cells (hMSCs) is the first listed.
NCT05925608 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05925608 about?
NCT05925608 is a clinical study titled "Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells". This clinical study will utilize allogenic bone marrow-derived culture-expanded MSC that are expanded from mesenchymal stem cells and delivered using the investigational Helix transendocardial delivery catheter as a therapy for ischemic HFrEF with reduced ejection fraction.
What is the current status of trial NCT05925608?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2023-08-23. Estimated completion is 2027-12.
What conditions does trial NCT05925608 study?
This clinical trial studies the following conditions: Heart Failure, Systolic.
What interventions are being tested in trial NCT05925608?
The interventions under investigation include: CardiALLO™ Human Allogenic Culture-expanded Bone marrow-derived Mesenchymal Stem Cells (hMSCs) (COMBINATION_PRODUCT), Diagnostic Catheterization (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05925608?
This trial is sponsored by BioCardia, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05925608 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure, Systolic
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05925608's enrollment target sits among peer trials
39 9th of 13 higher than 5 of 13 other Heart Failure, Systolic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure, Systolic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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