NCT05925608Active, not recruitingPhase 1/2
Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells
Phase I/II Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells (hMSCs) in Patients With Ischemic Heart Failure With Reduced Ejection Fraction (HFrEF)
Source: ClinicalTrials.gov · Last updated 12 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 39 (estimated)
- First submitted
- 22 Jun 2023
- Start date
- 23 Aug 2023
- Primary completion date
- Dec 2026
- Lead sponsor
- BioCardia, Inc.
- Diseases
- Heart failure
- NCT number
- NCT05925608
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 39
- From 23 Aug 2023 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Other cardiovascular or medical history parameters, as appropriate, that may preclude safe administration of the study treatment.
Who the study is looking for
- New York Heart Association (NYHA) Class II or III
- Diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction
- Left ventricular ejection fraction between 20% and 40%
- On stable, guideline-directed medical and device therapy, as appropriate
- NTproBNP level of \>500 pg/ml.
- Have inflammation \> 2 mg/L as measured by high-sensitivity C-reactive protein (hs-CRP) test.
Age in the registry: 21 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.