RecruitingPhase 1NCT06560762

Study in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

A Phase 1, Open Label, Multiple Ascending Dose Study to Assess Safety and Tolerability of STM-01 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)


Sponsor

Secretome Therapeutics

Enrollment

12 participants

Start Date

Mar 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A Phase 1, Open label, Multiple Ascending Dose Study to Assess Safety and Tolerability of STM-01 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new investigational drug in people with heart failure with preserved ejection fraction (HFpEF) — a form of heart failure where the heart muscle contracts normally but is too stiff, making it harder for the heart to fill with blood properly. **You may be eligible if...** - You have been diagnosed with stable heart failure (NYHA class II or III) for at least 6 months - Your heart's pumping function is 50% or above (preserved ejection fraction) - You have objective evidence of heart failure documented in your medical records - You have been on stable heart failure medications for at least 30 days **You may NOT be eligible if...** - You have hypertrophic cardiomyopathy or a storage disorder like amyloidosis or Fabry disease - You have uncontrolled or persistent atrial fibrillation without adequate blood thinning treatment - You are participating in another clinical drug study - You have a psychiatric condition that would prevent you from giving consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSTM01

Neonatal mesenchymal stem cells (nMSCs),


Locations(2)

Northwestern Medicine

Chicago, Illinois, United States

UT Southwestern Medical Center

Dallas, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06560762


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