Study in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: STM01.
- Who it may be relevant to
- Registry conditions: Heart Failure With Preserved Ejection Fraction (HFpEF). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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)
Interventions
- Drug STM01
Neonatal mesenchymal stem cells (nMSCs),
Primary outcome measures
- 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. [Time frame: Dose 1 (Day 0) till end of study (Day 56)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Northwestern Medicine — Chicago
- UT Southwestern Medical Center — Dallas
Identifiers
NCT: NCT06560762 · Phase 1 STM-01 HFpEF Study