Safety and Efficacy of YB-1113 in Treatment of POI

Официальное название

A Phase 1 Study of the Safety and Efficacy of YB-1113 in Treatment of Premature Ovarian Insufficiency (POI) Via Intravenous Infusion

Обзор

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).

Вмешательства

• Препарат YB-1113
  Human umbilical cord tissue-derived mesenchymal stem cells (hUC-MSC)

Первичные конечные точки

• Incidence of treatment-emergent adverse events (AE) [Срок оценки: 52 weeks]

Вторичные конечные точки (3)

• Blood anti-Müllerian hormone (AMH) level [Срок оценки: 2, 6, 12, 24, and 52 weeks]
• Follicle-stimulating hormone (FSH) and estradiol (E2) levels [Срок оценки: 2, 6, 12, 24, and 52 weeks]
• Antral follicle counts (AFC) [Срок оценки: 2, 6, 12, 24, and 52 weeks]

Критерии участия

Критерии включения

• 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).
• Subjects who are generally healthy by laboratory tests (normal complete blood count (CBC), comprehensive metabolic panel (CMP), and urinalysis) at screening
• For subjects who had contraception before, the duration of amenorrhea should be more than 3 months after discontinuation of the oral contraception pill (OCP) or more than 6 months after discontinuation of Depo Provera (or similar) therapies

Критерии исключения

• 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
• Subjects under hormonal treatments including hormone replacement therapy (HRT) for osteoporosis, cardiovascular disease, or recalcitrant vasomotor symptomatology.
• Washout period less than 3 months for HRT.
• Subjects with a history of breast cancer or other estrogen responsive cancer.
• Subjects with existing malignant neoplasm, under active management for malignant neoplasm or under active surveillance for malignant neoplasm.
• Subjects with history of thromboembolic events such as pulmonary embolism, stroke, or ischemic heart disease
• Subjects with uncontrolled hypertension, kidney disease, liver disease, or polycystic ovary syndrome (PCOS)
• Subjects with endocrinopathies including Cushing's disease, thyroid disease, congenital adrenal hyperplasia and hyperprolactinemia.
• Subjects under active management for autoimmune disease.
• Subjects with intra-uterine devices (IUDs).
• Subjects who are pregnant, breastfeeding, or whose urinary pregnancy test is positive before participation in the study.
• Subjects who are allergic to low-molecular-weight heparin sodium or human albumin.
• Subjects with polyglandular autoimmune disease or other conditions require chronic administration of steroids higher than 30 mg/day of hydrocortisone or its equivalent
• Subjects with hereditary or acquirement coagulopathies, including but not limited to hemophilia, Von Willebrand disease, liver disease, Vitamin K deficiency, and platelet disorders.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05494723 · YB1113-POI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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