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)
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Illinois
Northwestern Medicine
NOT_YET_RECRUITING
Chicago
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Malika Pasha
mpasha@secretometx.com
4155352700
Time Frame
Start Date: 2025-03-03
Estimated Completion Date: 2025-12-15
Participants
Target number of participants: 12
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Secretome Therapeutics