Ireland
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Recruiting Phase 1

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

NCT06560762 · tracked via the Priya Life Science USA tracker
Sponsor
Secretome Therapeutics
Phase
Phase 1
Started
2025-03-03
Last updated
2025-04-06

Condition(s) studied

Heart Failure With Preserved Ejection Fraction (HFpEF)

Investigational drug(s) / intervention(s)

STM01

STM01: Neonatal mesenchymal stem cells (nMSCs),

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Major Inclusion Criteria: * Stable New York Heart Association (NYHA) Class II or III HF diagnosis, evident at least 6 months prior to enrolment as confirmed by medical history. * Documented prior objective evidence of heart failure * Screening ejection fraction ≥50%. * Adequate bone marrow reserve and organ function at the Screening * Receiving standard of care heart failure therapy at stable doses for at least 30 days prior to Screening. Major Exclusion Criteria: * Participant in any other study and has received any other investigational drug within 30 days prior to screening or 5-half-lives, whichever is longer, or any other investigational implanted device within 30 days prior to screening, or are taking part in a nonmedication study which, in the opinion of the Investigator, would interfere with study compliance or outcome assessments. * Prior diagnosis of hypertrophic cardiomyopathy or a known infiltrative or storage disorder causing HFpEF and/or cardiac hypertrophy, such as amyloidosis, Fabry disease, or Noonan syndrome with LV hypertrophy. * Persistent or permanent atrial fibrillation and is not therapeutically anticoagulated for at least the 4 weeks prior to the initial screening visit or is not adequately rate controlled within 6 months prior to informed consent according to investigator discretion. * Other medical or psychiatric conditions that, in the opinion of the Investigator, would preclude obtaining voluntary consent/assent or would confound the objectives of the study.

Primary outcome measure(s)

  • Frequency, grade and relationship to STM-01 of unsolicited local and systemic AEs (any SAEs, MAAEs and AESIs ) during the 60-d follow-up period post IV infusion at D0 and D28 per the CTCAE v5.0 and clinical-safety laboratory parameters up to D 56. — Dose 1 (Day 0) till end of study (Day 56)

Trial sites (2)

FacilityCityRegionStatus
Northwestern Medicine Chicago Illinois Not Yet Recruiting
UT Southwestern Medical Center Dallas Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06560762 on ClinicalTrials.gov ↗ ← All trials in the USA