BioCardia Announces Positive DSMB Review of CardiALLO Allogeneic Cell Therapy for Heart Failure Phase 1/2 Clinical Trial
BioCardia (NASDAQ: BCDA) has received positive safety review from the independent Data Safety Monitoring Board (DSMB) for its CardiALLO-HF allogeneic cell therapy trial for heart failure. The DSMB recommended proceeding with the study as designed, following assessment of 30-day safety data from the initial 20 million cell dosing cohort.
The trial showed no treatment emergent major adverse cardiac events or clinical evidence of immune reactions to the allogeneic cells. The company plans to expand enrollment to 39 participants across the United States.
The CardiALLO HF trial at high dosage is expected to deliver at least double the effective dosage compared to previous studies and will uniquely target patients with active inflammation. Earlier clinical results from the TRIDENT trial demonstrated that higher MSC cell dosages reduced myocardial scar and increased left ventricular ejection fraction.
BioCardia (NASDAQ: BCDA) ha ricevuto una valutazione positiva sulla sicurezza dall'indipendente Data Safety Monitoring Board (DSMB) per il suo studio CardiALLO-HF sulla terapia cellulare allogenica per l'insufficienza cardiaca. Il DSMB ha raccomandato di procedere con lo studio così come progettato, dopo aver valutato i dati di sicurezza a 30 giorni del primo gruppo con dosaggio di 20 milioni di cellule.
Lo studio non ha evidenziato eventi avversi cardiaci maggiori emergenti dal trattamento né segni clinici di reazioni immunitarie alle cellule allogeniche. L'azienda prevede di ampliare il reclutamento a 39 partecipanti negli Stati Uniti.
Lo studio CardiALLO HF ad alto dosaggio dovrebbe fornire almeno il doppio della dose efficace rispetto agli studi precedenti e si concentrerà in modo specifico su pazienti con infiammazione attiva. Risultati clinici precedenti del trial TRIDENT hanno dimostrato che dosi più elevate di cellule MSC riducono la cicatrice miocardica e aumentano la frazione di eiezione ventricolare sinistra.
BioCardia (NASDAQ: BCDA) ha recibido una evaluación positiva de seguridad por parte del independiente Data Safety Monitoring Board (DSMB) para su ensayo de terapia celular alogénica CardiALLO-HF para insuficiencia cardíaca. El DSMB recomendó continuar con el estudio tal como está diseñado, tras evaluar los datos de seguridad a 30 días del primer grupo con dosis de 20 millones de células.
El ensayo no mostró eventos adversos cardíacos mayores relacionados con el tratamiento ni evidencia clínica de reacciones inmunitarias a las células alogénicas. La compañía planea ampliar la inscripción a 39 participantes en Estados Unidos.
Se espera que el ensayo CardiALLO HF con dosis altas proporcione al menos el doble de la dosis efectiva comparado con estudios anteriores y se enfocará específicamente en pacientes con inflamación activa. Resultados clínicos previos del ensayo TRIDENT demostraron que dosis más altas de células MSC reducen la cicatriz miocárdica y aumentan la fracción de eyección ventricular izquierda.
BioCardia (NASDAQ: BCDA)는 심부전 치료를 위한 동종 세포 치료제 CardiALLO-HF 임상시험에 대해 독립 데이터 안전성 모니터링 위원회(DSMB)로부터 긍정적인 안전성 평가를 받았습니다. DSMB는 초기 2천만 세포 투여 코호트의 30일 안전성 데이터를 평가한 후 설계된 대로 연구를 진행할 것을 권고했습니다.
임상시험에서는 치료 관련 주요 심장 이상 반응이나 동종 세포에 대한 면역 반응의 임상적 증거가 나타나지 않았습니다. 회사는 미국 내 39명의 참가자로 등록을 확대할 계획입니다.
고용량 CardiALLO HF 임상시험은 이전 연구보다 최소 두 배 이상의 유효 용량을 제공할 것으로 예상되며, 활성 염증이 있는 환자들을 독특하게 대상으로 합니다. 이전 TRIDENT 임상 결과는 더 높은 MSC 세포 용량이 심근 흉터를 줄이고 좌심실 박출률을 증가시킨다는 것을 보여주었습니다.
BioCardia (NASDAQ : BCDA) a reçu un avis positif sur la sécurité de la part du Data Safety Monitoring Board (DSMB) indépendant pour son essai de thérapie cellulaire allogénique CardiALLO-HF dans l’insuffisance cardiaque. Le DSMB a recommandé de poursuivre l’étude telle que conçue, après avoir évalué les données de sécurité à 30 jours issues de la cohorte initiale recevant une dose de 20 millions de cellules.
L’essai n’a révélé aucun événement cardiaque indésirable majeur lié au traitement ni aucune preuve clinique de réactions immunitaires aux cellules allogéniques. La société prévoit d’étendre le recrutement à 39 participants aux États-Unis.
L’essai CardiALLO HF à haute dose devrait fournir au moins le double de la dose efficace par rapport aux études précédentes et ciblera spécifiquement les patients présentant une inflammation active. Les résultats cliniques antérieurs de l’essai TRIDENT ont démontré que des doses plus élevées de cellules MSC réduisaient la cicatrice myocardique et augmentaient la fraction d’éjection ventriculaire gauche.
BioCardia (NASDAQ: BCDA) hat vom unabhängigen Data Safety Monitoring Board (DSMB) eine positive Sicherheitsbewertung für seine CardiALLO-HF-Allogen-Zelltherapie-Studie bei Herzinsuffizienz erhalten. Das DSMB empfahl, die Studie wie geplant fortzusetzen, nachdem die 30-Tage-Sicherheitsdaten der ersten Kohorte mit einer Dosierung von 20 Millionen Zellen bewertet wurden.
Die Studie zeigte keine behandlungsbedingten schweren kardialen Nebenwirkungen oder klinische Hinweise auf Immunreaktionen gegen die allogenen Zellen. Das Unternehmen plant, die Teilnehmerzahl in den USA auf 39 zu erhöhen.
Die CardiALLO HF-Studie mit hoher Dosierung soll mindestens die doppelte effektive Dosis im Vergleich zu früheren Studien liefern und richtet sich gezielt an Patienten mit aktiver Entzündung. Frühere klinische Ergebnisse der TRIDENT-Studie zeigten, dass höhere MSC-Zell-Dosierungen den Myokardnarbe reduzierten und die linksventrikuläre Ejektionsfraktion erhöhten.
- No adverse cardiac events or immune reactions observed in initial dosing cohort
- Trial advancement creates opportunities for non-dilutive funding and partnerships
- Previous trials showed higher MSC dosages reduced myocardial scar and increased left ventricular ejection fraction
- Potential for conditional approval and reimbursement in Japan
- Currently only completed initial low dosage group assessment
- Full trial results and higher dosage safety profile still pending
Insights
BioCardia's positive DSMB safety review for CardiALLO represents a critical milestone for the company's allogeneic cell therapy program in heart failure. The absence of treatment-emergent adverse cardiac events and immune reactions in the initial dosing cohort is particularly significant for an allogeneic ("off-the-shelf") cell therapy, as immunological rejection remains a key concern with this approach.
The green light to proceed with the higher enrollment phase (39 participants) maintains the company's development momentum for its lead program. For a micro-cap biotech with
Strategically, this safety clearance opens multiple potential pathways:
- Enables discussions for non-dilutive funding crucial for a capital-constrained company
- Creates potential partnering opportunities for their MSC platform
- Positions them for future pivotal trial design in the US
- Opens possibility for conditional approval with reimbursement in Japan (which has accelerated pathways for regenerative medicines)
- Expands into orphan indications including pediatric and adult congenital heart disease
The company's plan to use a higher cell dosage than previous studies ("at least twice the effective dosage") is supported by dose-response data from the TRIDENT trial showing improved cardiac function at higher MSC doses. Their targeted approach of selecting patients with active inflammation is also scientifically rational given previous findings of enhanced response in this population.
Independent Data Safety Monitoring Board (DSMB) recommends that the study proceeds as designed based on 30-day data safety assessment of participants treated in low dosage group.
The company plans to progress the trial to enrollment of 39 participants in the United States.
SUNNYVALE, Calif., April 15, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that the study’s independent DSMB, which conducted a planned review of the 30-day safety data from the roll-in 20 million cell dosing cohort in the CardiALLO-HF trial, recommended that the study continue as designed. There have been no treatment emergent major adverse cardiac events observed nor has there been any clinical evidence of immune reactions to the allogeneic cells implanted.
“We are pleased with the DSMB’s recommendation, an important step forward in advancing this allogeneic off the shelf mesenchymal stromal/stem cell therapy,” said Peter Altman, BioCardia Chief Executive Officer. “Today’s result has potential to be helpful with ongoing discussions around nondilutive funding and partnering opportunities for our MSC platform. Success in this trial can enable future pivotal trial design and funding in the USA, conditional time limited approval with reimbursement in Japan, as well as the advancement of CardiALLO MSC therapy for the likely orphan indications of pediatric and adult congenital heart disease.”
Previous clinical results of MSC in ischemic heart failure from our co-sponsored TRIDENT trial1 demonstrated that higher MSC cell dosages reduced myocardial scar and increased left ventricular ejection fraction, and peer results2 have indicated that patients with active inflammation have sustained reduction in cardiovascular major morbidity. CardiALLO HF at high dosage is anticipated to have at least twice the effective dosage of these previous studies and will be the first trial to target patients with active inflammation.
About CardiALLO HF
The CardiALLO Heart Failure Trial is a Phase I/II study with an open label Phase I nine-patient dose escalation cohort, followed by a thirty-patient randomized double-blinded placebo procedure-controlled cohort, intended to develop support for safety and efficacy of this treatment. For Phase I, three patients are to be treated at one of three escalating doses of 20 million cells, 100 million cells, and 200 million cells, using the efficient Helix minimally invasive delivery system. The proprietary CardiALLO human MSCs and their dedicated proprietary catheter delivery system are manufactured at BioCardia’s facility in Sunnyvale, California.
About BioCardia
BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms. For more information visit: www.BioCardia.com.
Forward Looking Statements
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to whether these results are helpful with ongoing discussions around nondilutive funding and partnering opportunities, what success in the CardiALLO HF trial enables, and what the ultimate dosage in CardiALLO HF is relative to other studies.
We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 26, 2025, under the caption titled “Risk Factors.” BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
(1) Florea V, Rieger AC, DiFede DL, El-Khorazaty J, Natsumeda M, Banerjee MN, Tompkins BA, Khan A, Schulman IH, Landin AM, Mushtaq M, Golpanian S, Lowery MH, Byrnes JJ, Hendel RC, Cohen MG, Valasaki K, Pujol MV, Ghersin E, Miki R, Delgado C, Abuzeid F, Vidro-Casiano M, Saltzman RG, DaFonseca D, Caceres LV, Ramdas KN, Mendizabal A, Heldman AW, Mitrani RD, Hare JM. Dose Comparison Study of Allogeneic Mesenchymal Stem Cells in Patients With Ischemic Cardiomyopathy (The TRIDENT Study). Circ Res. 2017 Nov 10;121(11):1279-1290. doi: 10.1161/CIRCRESAHA.117.311827. Epub 2017 Sep 18. PMID: 28923793; PMCID: PMC8742223.
(2) Perin EC, Borow KM, Henry TD, Jenkins M, Rutman O, Hayes J, James CW, Rose E, Skali H, Itescu S, Greenberg B. Mesenchymal precursor cells reduce mortality and major morbidity in ischaemic heart failure with inflammation: DREAM-HF. Eur J Heart Fail. 2024 Nov 26. doi: 10.1002/ejhf.3522. Epub ahead of print. PMID: 39593178.
Media Contact:
Miranda Peto, Investor Relations
Email: mpeto@BioCardia.com
Phone: 650-226-0120
Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120
FAQ
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