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)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Neonatal mesenchymal stem cells (nMSCs),
Northwestern Medicine
Chicago, Illinois, United States
NOT_YET_RECRUITINGUT Southwestern Medical Center
Dallas, Texas, United States
RECRUITINGFrequency, 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)
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