Core Insights - The Independent Data Safety Monitoring Board (DSMB) has recommended that the CardiALLO-HF trial proceed as planned based on a 30-day safety assessment of participants treated with a low dosage of 20 million cells [1][2] - BioCardia, Inc. is advancing its allogeneic mesenchymal stromal/stem cell therapy, which has potential implications for funding and partnerships [3] Company Overview - BioCardia, Inc. is a leader in cellular and cell-derived therapeutics aimed at treating cardiovascular and pulmonary diseases, with its headquarters in Sunnyvale, California [5] - The company has two main biotherapeutic platforms: CardiAMP® (autologous) and CardiALLO™ (allogeneic), with three clinical stage product candidates currently in development [5] Trial Details - The CardiALLO Heart Failure Trial is a Phase I/II study that includes a nine-patient dose escalation cohort followed by a thirty-patient randomized double-blinded placebo-controlled cohort [4] - The trial will evaluate three escalating doses of 20 million, 100 million, and 200 million cells, utilizing the Helix minimally invasive delivery system [4] Clinical Significance - Previous clinical results from the TRIDENT trial indicated that higher dosages of MSC reduced myocardial scar and improved left ventricular ejection fraction [3] - The CardiALLO HF trial is expected to target patients with active inflammation and aims to use at least twice the effective dosage compared to previous studies [3]
BioCardia Announces Positive DSMB Review of CardiALLO Allogeneic Cell Therapy for Heart Failure Phase 1/2 Clinical Trial