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Not yet recruiting NCT05494723

Safety and Efficacy of YB-1113 in Treatment of POI

Phase I Interventional POI

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: YB-1113.
Who it may be relevant to
Registry conditions: POI. Basic parameters: 18 years — 39 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

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

Primary outcome measures

  • Incidence of treatment-emergent adverse events (AE) [Time frame: 52 weeks]
Secondary outcome measures (3)
  • Blood anti-Müllerian hormone (AMH) level [Time frame: 2, 6, 12, 24, and 52 weeks]
  • Follicle-stimulating hormone (FSH) and estradiol (E2) levels [Time frame: 2, 6, 12, 24, and 52 weeks]
  • Antral follicle counts (AFC) [Time frame: 2, 6, 12, 24, and 52 weeks]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05494723 · YB1113-POI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗