Heart Failure With Preserved Ejection Fraction (HFpEF)
Investigational drug(s) / intervention(s)
STM01
STM01: Neonatal mesenchymal stem cells (nMSCs),
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
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)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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