Study in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Phase 1
Recruiting
- Conditions
- Heart Failure With Preserved Ejection Fraction (HFpEF)
- Interventions
- Registration Number
- NCT06560762
- Lead Sponsor
- Secretome Therapeutics
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 12
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
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose arm (2 cohorts; 2 doses) STM01 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.
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Northwestern Medicine
🇺🇸Chicago, Illinois, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States