Secretome Therapeutics Launches Phase 1 Trial of STM-01 Cell Therapy for Dilated Cardiomyopathy
Key Insights
Secretome Therapeutics (search) has initiated a Phase 1 dose-escalating trial of STM-01, a neonatal cardiac progenitor cell therapy, for treating heart failure (search) in young adults with dilated cardiomyopathy (search).
The trial is funded by The Marcus Foundation (search) and will take place at Children's Healthcare of Atlanta, with a subsequent pediatric DCM (search) study planned if safety is demonstrated.
Pediatric DCM (search) affects 500-1,000 children in the US annually, with diagnosis typically at 2 years of age and a 5-year life expectancy without heart transplantation.
Secretome Therapeutics (search) announced the launch of a Phase 1, dose-escalating clinical trial of STM-01, the company's neonatal cardiac progenitor cell (nCPC) product, for treating heart failure (search) in young adults with dilated cardiomyopathy (search) (DCM). The trial, funded through a grant from The Marcus Foundation (search), will be conducted at Children's Healthcare of Atlanta.
Novel Cell Therapy Approach
STM-01 represents a first-in-class cellular therapy designed to modulate inflammatory and fibrotic pathways while supporting myocardial function in DCM patients. The therapy is derived from neonatal cardiac progenitor cells (search), which preclinical studies suggest offer superior therapeutic potential compared to existing cell-based approaches.
"Our preclinical published results in animals suggest that, compared to mesenchymal stem cells from older donors, STM-01 is uniquely potent at improving ejection fraction and treating heart failure (search)," said Michael Davis, Ph.D., Director of the Emory and Children's Heart Research and Outcomes Center and Professor of Cardiology and Biomedical Engineering at the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University.
Addressing Critical Unmet Need
Pediatric DCM (search) represents a rare but life-threatening form of heart failure (search) affecting between 500 and 1,000 children in the United States annually. The disease is typically diagnosed at an average age of 2 years, and without heart transplantation, patients face an average life expectancy of just 5 years following diagnosis.
The Phase 1 trial will initially study the safety of multiple ascending doses of STM-01 in adult patients with DCM. If the therapy demonstrates safety and tolerability, STM-01 will advance to a Phase 1 multiple ascending dose study in pediatric DCM (search) patients. Both trials will be conducted at the Marcus Center for Cellular Therapy at Children's Arthur M. Blank Hospital.
Preclinical Evidence
The clinical advancement of STM-01 is supported by preclinical studies conducted in the laboratories of Michael Davis, Ph.D. at Emory University and Georgia Tech, and Sunjay Kaushal, M.D., Ph.D. at the University of Maryland, Baltimore. These studies demonstrated that neonatal cardiac progenitor cells (search) produce marked improvements in cardiac function in both adult and juvenile animal models of heart failure (search).
"The launch of this clinical study is the first step towards offering a new class of therapies to adult and pediatric patients suffering from DCM," said Vinny Jindal, President and Chief Executive Officer of Secretome Therapeutics (search). "We are honored to work with the teams at Children's, Emory, and The Marcus Foundation (search) to study STM-01 in this lethal and underserved disease."
Company Pipeline
Beyond STM-01, Secretome Therapeutics (search) is developing additional applications for its neonatal cardiac progenitor cell platform. The company is also advancing STM-21, a secretome-based therapeutic currently in preclinical development for inflammatory conditions, including skin wounds and diabetes-associated co-morbidities.