BioCardia’s Allogeneic NK1R+ Human Mesenchymal Stem Cells to Be Studied for Ischemic Heart Failure in FIH Trial

December 12, 2022—BioCardia, Inc., a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, recently announced FDA approval of the company’s investigational new drug application to initiate a first-in-human phase 1/2 clinical trial of its neurokinin-1 receptor positive (NK1R+) allogeneic human mesenchymal stem cell (MSC) therapy for the treatment of patients with ischemic heart failure.

According to the company, the CardiALLO trial is designed for patients with New York Heart Association class II and III ischemic heart failure with reduced ejection fraction whose cell composition makes them ineligible for the company’s phase 3 CardiAMP heart failure trial studying autologous cell therapy that has received FDA Breakthrough Device designation.

BioCardia, which is headquartered in Sunnyvale, California, has two biotherapeutic platforms: CardiAMP autologous bone marrow–derived mononuclear cell therapy for cardiovascular indications and the NK1R+ allogeneic bone marrow–derived MSC therapy for cardiovascular and pulmonary diseases. These platforms underly several clinical-stage product candidates.

Allogeneic NK1R+ MSCs are culture-expanded, bone marrow–derived MSCs that are NK1R+. Neurokinin 1 is the primary receptor for Substance P, an important neuropeptide mediator of inflammation. The BioCardia cell therapy consists of cells from younger, extensively prescreened donors that are expanded to provide multiple dosage forms from a single donor. The cells are manufactured by BioCardia at its Sunnyvale facility.

For the heart failure indication, these cells will be delivered to the heart using BioCardia’s Helix biotherapeutic delivery system, which is approved in the European Union and has been shown to result in three times as many cells being retained in the target heart tissue as competitive delivery approaches while having the lowest incidence of serious adverse events, noted the company’s press release.

In August 2022, BioCardia announced that the independent data safety monitoring board completed its prespecified data review for the ongoing phase 3 pivotal CardiAMP cell therapy heart failure trial. The ongoing multicenter, double-blind, randomized (3:2) controlled pivotal trial is expected to enroll 260 patients at up to 40 centers in the United States and Canada. BioCardia initiated the trial in 2017.