Secretome Therapeutics Begins Phase 1 Trial of STM-01 for Heart Failure with First Patient Dosed

PLANO, TX & BALTIMORE, MD, USA I March 25, 2025 I Secretome Therapeutics, a biotechnology firm at the clinical stage of development, has commenced the dosing of the first patient in its Phase 1 clinical trial. This trial is focused on evaluating STM-01, a novel therapy derived from neonatal cardiac progenitor cells (nCPC), for treating heart failure with preserved ejection fraction (HFpEF).

This clinical trial marks the initial study of an allogeneic, off-the-shelf stem cell therapy targeted at HFpEF, which is a predominant cause of hospital admissions, morbidity, and mortality globally. In the United States alone, approximately 6.7 million adults suffer from heart failure, with HFpEF accounting for at least half of these instances.

Dr. Sanjiv Shah, the Stone Endowed Professor and Director of the HFpEF Program at Northwestern University Feinberg School of Medicine, serves as the Principal Investigator of the STM-01 study. He highlighted that despite recent progress in treatments for HFpEF, the residual risk remains significant, with many patients' conditions continuing to deteriorate. According to Dr. Shah, the next phase in enhancing patient outcomes involves better management of inflammation and the restoration of normal cellular immunity. Preclinical studies have shown that STM-01 notably decreased inflammation at both the cellular and molecular levels in HFpEF, leading to improved cardiac function and exercise capability.

The Phase 1 clinical trial is a first-in-human, multiple-ascending dose, open-label study. Its main aim is to evaluate the safety, tolerability, and exploratory efficacy of STM-01 in individuals diagnosed with HFpEF. Patients participating in the study will receive an infusion of either 100 million or 200 million nCPC intravenously over the course of an hour. The first patient has been enrolled at The University of Texas, Southwestern Medical Center (UTSW), and is under the care of Dr. Ambarish Pandey, an Associate Professor of Internal Medicine at UTSW.

Dr. Pandey commented on the complexity and multifaceted nature of HFpEF. He emphasized that STM-01’s capacity to diminish fibrosis and enhance mitochondrial function, along with its anti-inflammatory properties, provides a robust scientific basis for testing it within this patient demographic.

Vinny Jindal, the President and CEO of Secretome Therapeutics, expressed that initiating their first clinical trial signifies a major achievement for the STM-01 program and the company. Secretome Therapeutics has recently secured numerous patents for STM-01, launched large-scale GMP manufacturing, completed its Seed Round of financing, and now commenced this Phase 1 study. These developments position the company effectively to advance STM-01 as a potentially transformative therapeutic solution in a market valued at multiple billions of dollars.

Secretome Therapeutics is dedicated to developing innovative regenerative medicines derived from nCPC for severe diseases with significant unmet needs. The company is pioneering a new class of biologic therapies that are off-the-shelf and designed to trigger the body’s natural repair mechanisms by utilizing the therapeutic potential of cell-secreted bioactive factors.