Recruiting
Phase 1

Heart Failure

Sponsor:

Secretome Therapeutics

Code:

NCT06560762

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

STM01

Study Details

Brief 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)

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF)

Study ID

NCT06560762

Start date

Mar 3, 2025

Status verified date

Apr, 2025

Completion date

Dec 15, 2025

Anticipated

Primary completion date

Dec 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Dose arm (2 cohorts; 2 doses)

Up to 12 participants will be enrolled (Up to 6 participants, for 5 completers per cohort). Each successive cohort of participants will receive STM-01 at the following doses: 100.0 x 106 nMSCs, and 200.0 x 106 nMSCs.

Interventions

STM01

Neonatal mesenchymal stem cells (nMSCs),

Primary outcome measure

  • 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. [ Time Frame: Dose 1 (Day 0) till end of study (Day 56) ]

Central Contacts and Locations

Central contacts

Malika Pasha

4155352700mpasha@secretometx.com

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

More Information

Sponsor

Secretome Therapeutics

Last update posted

Apr 6, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Secretome Therapeutics on 2025-04-06.