Last reviewed · How we verify
NCT06258447
CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction
NA trial testing Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system in Ischemic Heart Failure in 250 participants. Currently enrolling.
1 April 2027
Quick facts
| Lead sponsor | BioCardia, Inc. |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 250 |
| Start date | 1 August 2024 |
| Primary completion | 1 April 2027 |
| Estimated completion | 1 April 2029 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system
Conditions studied
- Ischemic Heart Failure — all drugs for Ischemic Heart Failure →
Sponsor
BioCardia, Inc. — full company profile →
Who can join
Adults 21 to 90, any sex, with Ischemic Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Concentrated autologous bone marrow mononuclear cells (ABM MNC) contain potentially therapeutic cell factors and past studies support therapeutic benefit to patients with cardiac diseases of acute myocardial infarction, ischemia, and heart failure when utilized as this study is designed. The purpose of the study is to determine the safety and efficacy of CardiAMP cell therapy system in patients with ischemic heart failure. It is a prospective, multi-center, randomized, controlled, patient and evaluator-blinded study comparing treatment with the CardiAMP cell therapy system to a control procedure with diagnostic catheterization.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Stem cell therapy for patients with acute myocardial infarction: a systematic review of clinical trials.
Mahram H, Khalafi V, Arman A, Mirhosseini SA, et al · · 2025 · PMID 41469916 · DOI 10.1186/s13287-025-04882-6
Verify or expand the search:
- PubMed search for NCT06258447
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other BioCardia, Inc. trials
Trials by the same sponsor.
- NCT05491681 — AllogeneiC Expanded Human MSC Therapy in Patients Recovering From COVID-19 Acute Respiratory Distress Trial · Phase 1 · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06258447 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by BioCardia, Inc.
- Last refreshed: 9 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06258447.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing