Safety and Efficacy of YB-1113 in Treatment of POI
ConditionPOI
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-39
SponsorBright Cell, Inc.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female, 18 to <40 years old, who are seeking fertility or preservation of fertility
Oligo/Amenorrhea for at least 4 months
At least two menopausal FSH levels (≥ 25 IU/L) with 4 to 6 weeks interval.
AMH levels ≤ 1.0 ng/mL (measured on day 2-5 of the menstrual period).
Disqualifiers
1. Primary amenorrhea or FSH ≥ 40 IU/L
Presence of contraindications to pregnancy
POI due to cytotoxic chemotherapy or radiation therapy
Subjects with FMR1 premutation (fragile X syndrome), a BMP15 mutation or family history of POI
Trial design
Design model
Sequential
Treatments tested in this trial
YB-1113
DrugHuman umbilical cord tissue-derived mesenchymal stem cells (hUC-MSC)
Treatment groups
6 Participants
are divided into 2 treatment groupsGroup A: Low-doseExperimental treatment 1 intervention
Group B: High-doseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of treatment-emergent adverse events (AE)
Reported treatment-related AE and serious adverse events (SAE)
Time frame
52 weeksSecondary outcomes
1
Blood anti-Müllerian hormone (AMH) level
Changes of AMH level from baseline
Time frame
2, 6, 12, 24, and 52 weeks2
Follicle-stimulating hormone (FSH) and estradiol (E2) levels
Changes of FSH and E2 from baseline
Time frame
2, 6, 12, 24, and 52 weeks3
Antral follicle counts (AFC)
Changes of AFC numbers from baseline
Time frame
2, 6, 12, 24, and 52 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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