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Comprehensive overview of Revascor®'s clinical development program, from groundbreaking Phase 3 results to ongoing regulatory pathway toward FDA approval.
Randomized Trial of Targeted Transendocardial Mesenchymal Precursor Cell Therapy
The largest randomized controlled trial of cell therapy for heart failure, evaluating the safety and efficacy of a single injection of mesenchymal precursor cells in patients with chronic heart failure and reduced ejection fraction.
Recurrent heart failure-related major adverse cardiac events (HF-MACE)
Revascor® in End-Stage Heart Failure Patients with Left Ventricular Assist Device
Pivotal study demonstrating remarkable survival benefit in the sickest heart failure patients, leading to FDA's support for accelerated approval pathway.
Safety and preliminary efficacy in LVAD patients
Hypoplastic Left Heart Syndrome Stage II/III Surgery
Groundbreaking study showing potential to transform outcomes for children with the most severe form of congenital heart disease.
Left ventricular development and biventricular conversion feasibility
Post-Approval Confirmatory Trial for Accelerated BLA
Required confirmatory trial as part of accelerated approval pathway, designed in alignment with FDA guidance.
Additional Studies in Congenital Heart Disease
Leveraging dual RMAT designation to expand Revascor® development across multiple congenital heart disease indications.
Primary publication of DREAM-HF Phase 3 results showing cardiovascular benefits in heart failure patients.
Read PublicationTrial design and biological rationale for mesenchymal precursor cell therapy in advanced heart failure.
Read PublicationAnalysis focusing on inflammation subgroup showing sustained mortality benefits.
Read PublicationExpert review and roadmap for future clinical development of cell-based heart failure therapies.
Read PublicationFDA provided formal minutes confirming alignment on all key BLA requirements including CMC, potency assays, and confirmatory trial design.
Second RMAT designation granted for children with congenital heart disease, enabling accelerated development.
Original RMAT designation for adult heart failure, recognizing potential to address significant unmet medical need.
FDA granted Orphan Drug Designation for Revascor® in children with congenital heart disease.