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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose | Experimental | Low-dose YB-1113 |
|
| High-dose | Experimental | High-dose YB-1113 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YB-1113 | Drug | Human umbilical cord tissue-derived mesenchymal stem cells (hUC-MSC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (AE) | Reported treatment-related AE and serious adverse events (SAE) | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood anti-Müllerian hormone (AMH) level | Changes of AMH level from baseline | 2, 6, 12, 24, and 52 weeks |
| Follicle-stimulating hormone (FSH) and estradiol (E2) levels | Changes of FSH and E2 from baseline |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Wang | Contact | 949-333-3636 | jenniferw@brightcellinc.com |
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| 2, 6, 12, 24, and 52 weeks |
| Antral follicle counts (AFC) | Changes of AFC numbers from baseline | 2, 6, 12, 24, and 52 weeks |