Heart Failure With Preserved Ejection Fraction (HFpEF)
Conditions
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)
Interventions
DRUGSTM01
Neonatal mesenchymal stem cells (nMSCs),
Sponsors
Secretome Therapeutics
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) |
Countries
United States
Contacts
Primary ContactMalika Pasha
Outcome results
None listed