This phase 1 study is to evaluate the safety and tolerability of YB-1113 administered via intravenous (IV) infusion in the treatment of premature ovarian insufficiency (POI).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Human umbilical cord tissue-derived mesenchymal stem cells (hUC-MSC)
Incidence of treatment-emergent adverse events (AE)
Reported treatment-related AE and serious adverse events (SAE)
Time frame: 52 weeks
Blood anti-Müllerian hormone (AMH) level
Changes of AMH level from baseline
Time frame: 2, 6, 12, 24, and 52 weeks
Follicle-stimulating hormone (FSH) and estradiol (E2) levels
Changes of FSH and E2 from baseline
Time frame: 2, 6, 12, 24, and 52 weeks
Antral follicle counts (AFC)
Changes of AFC numbers from baseline
Time frame: 2, 6, 12, 24, and 52 weeks
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