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

NCT06560762 | Recruiting Phase 1 FDA Drug

• 1 other identifier: Phase 1 STM-01 HFpEF Study
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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)

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Dose arm (2 cohorts; 2 doses)

OTHER

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.

Drug: STM01

Interventions

STM01 DRUG

Neonatal mesenchymal stem cells (nMSCs),

Dose arm (2 cohorts; 2 doses)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Secretome Therapeutics: lead

Study Sites (2)

Northwestern Medicine

Chicago, Illinois, 60611-5969, United States

NOT YET RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Central Study Contacts

Malika Pasha

CONTACT

4155352700; mpasha@secretometx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase 1, open-label, multi-center, dose-ranging study evaluating the safety and tolerability of STM-01 administered by intravenous infusion in participants with HFpEF. Up to 12 participants (2 cohorts) 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.

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 19, 2024
• Study Start: March 3, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

US (2)