BioCardia®?, Inc. announced that the first patient was enrolled and treated in its CardiALLO?? Allogeneic Mesenchymal Cell Therapy Phase I/II trial for the treatment of patients with New York Heart Association Class II and III ischemic heart failure of reduced ejection fraction (HFrEF). These "off the shelf" mesenchymal stem cells (MSC) utilized for the study treatment are immunomodulatory with potential for impact on inflammatory processes in heart failure and have been shown to release multiple critical angiogenic factors that can enhance microvascular function and capillary networks in ischemic tissues.

They are closely related to the MSC used in previous experience with HFrEF patients, which demonstrated significant and durable reduction in infarct size and enhanced left ventricular ejection fraction following a single dose. The CardiALLO MSC study is a dose escalation Phase I safety study to be followed by a Phase II randomized double-blind controlled study to assess therapeutic benefit or efficacy. In Phase I, the study calls for at least nine New York Heart Association Class II or III HFrEF patients to be initially enrolled, with an additional 60 patients enrolled in Phase II.

For Phase I, three patients are to be treated at each of three escalation doses, 20 million cells, 100 million cells, and 200 million cells, using BioCardia's minimally invasive Helix catheter delivery system which enters the heart through a blood vessel. These proprietary CardiALLO human cells and their dedicated proprietary catheter delivery system are manufactured at BioCardia's facility in Sunnyvale, California. This study follows BioCardia's three previous co-sponsored clinical trials with MSCs in ischemic heart failure: TACHFT1, POSEIDON2 and TRIDENT3.

These trials included 93 patients treated with culture expanded MSCs or dedicated controls using the Helix delivery system with no observed treatment emergent serious adverse events. The CardiallO MSC trial builds on the compelling early signals for benefit demonstrated in these previous trials. Anticipated 2023 Fourth Quarter Milestones: Helix Biotherapeutic Delivery System Update on Licensing /Partnerships.