Safety and Efficacy of YB-1113 in Treatment of POI

NCT ID: NCT05494723

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-12-09
• Study Completion Date: 2028-04-09

Brief Summary

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).

Conditions

POI

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low-dose

Low-dose YB-1113

Group Type: EXPERIMENTAL

YB-1113

Intervention Type: DRUG

Human umbilical cord tissue-derived mesenchymal stem cells (hUC-MSC)

High-dose

High-dose YB-1113

Group Type: EXPERIMENTAL

YB-1113

Intervention Type: DRUG

Human umbilical cord tissue-derived mesenchymal stem cells (hUC-MSC)

Interventions

YB-1113

Human umbilical cord tissue-derived mesenchymal stem cells (hUC-MSC)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Female, 18 to <40 years old, who are seeking fertility or preservation of fertility

2. Oligo/Amenorrhea for at least 4 months

3. At least two menopausal FSH levels (≥ 25 IU/L) with 4 to 6 weeks interval.

4. AMH levels ≤ 1.0 ng/mL (measured on day 2-5 of the menstrual period).

5. Subjects who are generally healthy by laboratory tests (normal complete blood count (CBC), comprehensive metabolic panel (CMP), and urinalysis) at screening

6. 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. 1. Primary amenorrhea or FSH ≥ 40 IU/L

2. Presence of contraindications to pregnancy

3. POI due to cytotoxic chemotherapy or radiation therapy

4. Subjects with FMR1 premutation (fragile X syndrome), a BMP15 mutation or family history of POI

5. Subjects under hormonal treatments including hormone replacement therapy (HRT) for osteoporosis, cardiovascular disease, or recalcitrant vasomotor symptomatology.

6. Washout period less than 3 months for HRT.

7. Subjects with a history of breast cancer or other estrogen responsive cancer.

8. Subjects with existing malignant neoplasm, under active management for malignant neoplasm or under active surveillance for malignant neoplasm.

9. Subjects with history of thromboembolic events such as pulmonary embolism, stroke, or ischemic heart disease

10. Subjects with uncontrolled hypertension, kidney disease, liver disease, or polycystic ovary syndrome (PCOS)

11. Subjects with endocrinopathies including Cushing's disease, thyroid disease, congenital adrenal hyperplasia and hyperprolactinemia.

12. Subjects under active management for autoimmune disease.

13. Subjects with intra-uterine devices (IUDs).

14. Subjects who are pregnant, breastfeeding, or whose urinary pregnancy test is positive before participation in the study.

15. Subjects who are allergic to low-molecular-weight heparin sodium or human albumin.

16. Subjects with polyglandular autoimmune disease or other conditions require chronic administration of steroids higher than 30 mg/day of hydrocortisone or its equivalent

17. Subjects with hereditary or acquirement coagulopathies, including but not limited to hemophilia, Von Willebrand disease, liver disease, Vitamin K deficiency, and platelet disorders.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bright Cell, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jennifer Wang

Role: CONTACT

Phone: 949-333-3636

Email: jenniferw@brightcellinc.com

Other Identifiers

YB1113-POI

Identifier Type: -

Identifier Source: org_study_id