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

Secretome Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Heart Failure With Preserved Ejection Fraction (HFpEF)

Treatments: Drug: STM01

Study type: Interventional

Funder types: Industry

Identifiers

NCT06560762

Phase 1 STM-01 HFpEF Study

Details and patient eligibility

About

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)

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Dose arm (2 cohorts; 2 doses)

Other group

Description:

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.

Treatment:

Drug: STM01