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

NCT ID: NCT06560762

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-03
• Study Completion Date: 2025-12-15

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 Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

STM01

Intervention Type: DRUG

Neonatal mesenchymal stem cells (nMSCs),

Interventions

STM01

Neonatal mesenchymal stem cells (nMSCs),

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Secretome Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Northwestern Medicine

Chicago, Illinois, United States

Site Status: NOT_YET_RECRUITING

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Malika Pasha

Role: CONTACT

mpasha@secretometx.com

4155352700

Other Identifiers

Phase 1 STM-01 HFpEF Study

Identifier Type: -

Identifier Source: org_study_id