PLANO, TX & BALTIMORE, MD, USA I March 25, 2025 I Secretome Therapeutics, a clinical-stage biotechnology company developing novel therapies derived from neonatal cardiac progenitor cells (nCPC), today announced dosing of the first patient in its Phase 1 clinical trial evaluating STM-01 as a treatment for heart failure with preserved ejection fraction (HFpEF).
This is the first-ever clinical study of an allogeneic, off-the-shelf stem cell therapy in HFpEF, a leading cause of hospitalization, morbidity, and mortality worldwide. An estimated 6.7 million adults in the U.S. are affected by heart failure, with HFpEF comprising at least half of these cases.
“Despite recent advances that have improved outcomes in HFpEF, residual risk is still very high and many of these patients will continue to worsen,” said Sanjiv Shah, M.D., the Stone Endowed Professor and Director of the HFpEF Program at the Northwestern University Feinberg School of Medicine, and Principal Investigator of the STM-01 study in HFpEF. “The next step in improving outcomes for patients is better and broader control of inflammation and restoration of normal cellular immunity. In preclinical studies, STM-01 significantly reduced inflammation on both cellular and molecular levels in HFpEF, resulting in improved cardiac function and exercise tolerance.”
The Phase 1 clinical trial is a first-in-human, multiple-ascending dose, open-label study designed to assess the safety, tolerability, and exploratory efficacy of STM-01 in patients diagnosed with HFpEF. Patients will receive either 100 million or 200 million nCPC infused intravenously over one hour. The first patient was enrolled at The University of Texas, Southwestern Medical Center (UTSW), under the care of Dr. Ambarish Pandey, Associate Professor of Internal Medicine at UTSW.
“HFpEF is a complex and multifactorial disease, and STM-01’s ability to reduce fibrosis and improve mitochondrial function, in addition to its anti-inflammatory effects, provide a strong scientific rationale to test it in this patient population,” said Dr. Pandey.
“The launch of our first clinical trial is a major milestone for the STM-01 program, and for Secretome,” said Vinny Jindal, President and Chief Executive Officer of Secretome Therapeutics. “Having recently secured multiple patents for STM-01, launched large-scale GMP manufacturing, completed our Seed Round of financing, and now launched this Phase 1 study, we are well positioned to develop STM-01 as a potentially transformative therapeutic option in this multi-billion-dollar market.”
About Secretome Therapeutics
Secretome Therapeutics is a clinical-stage biotechnology company developing novel regenerative medicines derived from neonatal cardiac progenitor cells (nCPC) for serious diseases with high unmet need. By harnessing the therapeutic potential of cell-secreted bioactive factors, Secretome Therapeutics is pioneering a new class of off-the-shelf biologic therapies designed to activate the body’s natural repair mechanisms.
SOURCE: Secretome Therapeutics
Post Views: 253
PLANO, TX & BALTIMORE, MD, USA I March 25, 2025 I Secretome Therapeutics, a clinical-stage biotechnology company developing novel therapies derived from neonatal cardiac progenitor cells (nCPC), today announced dosing of the first patient in its Phase 1 clinical trial evaluating STM-01 as a treatment for heart failure with preserved ejection fraction (HFpEF).
This is the first-ever clinical study of an allogeneic, off-the-shelf stem cell therapy in HFpEF, a leading cause of hospitalization, morbidity, and mortality worldwide. An estimated 6.7 million adults in the U.S. are affected by heart failure, with HFpEF comprising at least half of these cases.
“Despite recent advances that have improved outcomes in HFpEF, residual risk is still very high and many of these patients will continue to worsen,” said Sanjiv Shah, M.D., the Stone Endowed Professor and Director of the HFpEF Program at the Northwestern University Feinberg School of Medicine, and Principal Investigator of the STM-01 study in HFpEF. “The next step in improving outcomes for patients is better and broader control of inflammation and restoration of normal cellular immunity. In preclinical studies, STM-01 significantly reduced inflammation on both cellular and molecular levels in HFpEF, resulting in improved cardiac function and exercise tolerance.”
The Phase 1 clinical trial is a first-in-human, multiple-ascending dose, open-label study designed to assess the safety, tolerability, and exploratory efficacy of STM-01 in patients diagnosed with HFpEF. Patients will receive either 100 million or 200 million nCPC infused intravenously over one hour. The first patient was enrolled at The University of Texas, Southwestern Medical Center (UTSW), under the care of Dr. Ambarish Pandey, Associate Professor of Internal Medicine at UTSW.
“HFpEF is a complex and multifactorial disease, and STM-01’s ability to reduce fibrosis and improve mitochondrial function, in addition to its anti-inflammatory effects, provide a strong scientific rationale to test it in this patient population,” said Dr. Pandey.
“The launch of our first clinical trial is a major milestone for the STM-01 program, and for Secretome,” said Vinny Jindal, President and Chief Executive Officer of Secretome Therapeutics. “Having recently secured multiple patents for STM-01, launched large-scale GMP manufacturing, completed our Seed Round of financing, and now launched this Phase 1 study, we are well positioned to develop STM-01 as a potentially transformative therapeutic option in this multi-billion-dollar market.”
About Secretome Therapeutics
Secretome Therapeutics is a clinical-stage biotechnology company developing novel regenerative medicines derived from neonatal cardiac progenitor cells (nCPC) for serious diseases with high unmet need. By harnessing the therapeutic potential of cell-secreted bioactive factors, Secretome Therapeutics is pioneering a new class of off-the-shelf biologic therapies designed to activate the body’s natural repair mechanisms.
SOURCE: Secretome Therapeutics
Post Views: 253
