Clinical Pipeline of Neonatal Cardiac Progenitor Cell (nCPC) Therapies

Note: Heart Failure with Preserved Ejection Fraction (HFpEF), Dilated Cardiomyopathy (DCM), DMD-related cardiomyopathy (DMD-CM)

Platform

Secretome Therapeutics is developing investigational therapies derived from neonatal cardiac progenitor cells and stromal cell biology. In preclinical studies, neonatal cardiac-derived cells and their secretome (including extracellular vesicles such as exosomes) have demonstrated coordinated biological activity relevant to cardiac repair.

Across multiple cardiac injury models, neonatal cardiac-derived cell populations have been associated with improvements in ventricular function, reductions in fibrosis, and modulation of immune cell profiles consistent with a pro-repair environment.

Programs in Development

• STM-01 (investigational): Neonatal cardiac progenitor cell therapy in Phase 1 clinical development for heart failure indications, including HFpEF and DCM.
• STM-21 (investigational): Extracellular vesicle/exosome-based program derived from neonatal cardiac cells, designed to translate key paracrine biology into a scalable therapeutic product.
• STM-03 (investigational): Next-generation engineered-cell platform under development for cardiovascular and orphan indications.

Lead indication focus: Duchenne-Associated Cardiomyopathy (DMD-CM)

Duchenne muscular dystrophy (DMD) is a progressive genetic disorder characterized by muscle degeneration and significant cardiac morbidity. Cardiomyopathy remains a leading cause of mortality in patients with DMD.

In preclinical models, neonatal cardiac-derived cells and their secretome have demonstrated improvements in ventricular function and fibrosis, along with immunomodulatory effects including increased regulatory T cells. These findings support continued evaluation of our platform biology in DMD-associated cardiac disease.

Selected Peer-Reviewed Publications

Circulating exosomes derived from transplanted progenitor cells aid the functional recovery of ischemic myocardium
Science Translational Medicine. 2019;11:eaau1168.
In a xenogeneic rodent myocardial infarction model, cardiac progenitor cells (CPCs) demonstrated greater functional recovery compared with cardiosphere-derived cells (CDCs), including improvements in left ventricular ejection fraction (LVEF). The study further characterized circulating CPC-derived exosomes and their microRNA cargo as potential mediators of myocardial recovery.

A Deep Proteome Analysis Identifies the Complete Secretome as the Functional Unit of Human Cardiac Progenitor Cells
Circulation Research. 2017;120:816–834.
This study compared neonatal and adult cardiac progenitor cells (nCPCs and aCPCs) in preclinical myocardial infarction models and reported enhanced recovery of cardiac function parameters, including LVEF, with neonatal cells. Comprehensive proteomic analysis identified distinct secretome profiles and upstream regulatory pathways that may contribute to functional differences between neonatal and adult CPCs.

Comparative efficacy and mechanism of action of cardiac progenitor cells after cardiac injury
iScience. 2022;25:104656.
In head-to-head preclinical comparisons across multiple clinically relevant stem and progenitor cell populations, neonatal cardiac-derived cells demonstrated greater improvements in cardiac functional parameters, reduced fibrosis, and modulation of immune cell populations, including increased regulatory T cells. Mechanistic analyses identified pathways influencing cell retention, immune evasion, and secretome composition.

Important notice: Product candidates are investigational. References to preclinical or clinical studies are provided for scientific information only. No product candidate has been approved by the FDA or any other regulatory authority.