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Study of STM-01 for Heart Failure with Preserved Ejection Fraction (HFpEF)

This study is testing a treatment called STM-01, which uses neonatal mesenchymal stem cells (nMSCs), for people with Heart Failure with Preserved Ejection Fraction (HFpEF). HFpEF is a type of heart failure where the heart muscle is stiff and can't relax properly to fill with blood. This is a Phase 1 study, meaning its main goal is to check the safety and tolerability of STM-01. Researchers will be looking for any side effects or problems related to the treatment. You may be able to join if you are 18 or older, have stable NYHA Class II or III HFpEF for at least 6 months, and have an ejection fraction (a measure of how well your heart pumps blood) of 50% or more. The study plans to enroll 12 participants, but its current status is unclear.

Study design
This is a Phase 1, open-label study, meaning both you and the study team will know which treatment you are receiving. It involves multiple ascending doses of STM-01 and plans to enroll 12 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 60 days after your last treatment, with safety measurements taken up to Day 56.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06560762

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Secretome Therapeutics
~12 participants
Updated 2025-04-06 on ClinicalTrials.gov
What's tested:STM01

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over Dose 1 (Day 0) till end of study (Day 56)

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF)

Explore related trials

Heart Failure

NCT06560762

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Northwestern Medicine

    Chicago, Illinoisno site contact published

    Not yet recruiting

  • UT Southwestern Medical Center

    Dallas, Texasno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Malika Pasha
[email protected]
4155352700
Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • 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)