Safety and Efficacy of YB-1113 in Treatment of POI

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: POI
• Intervention / Treatment: Drug: YB-1113

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jennifer Wang; Phone Number: 949-333-3636; Email: jenniferw@brightcellinc.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No

Description

Key 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

Key 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-dose; Low-dose YB-1113	Drug: YB-1113; Human umbilical cord tissue-derived mesenchymal stem cells (hUC-MSC)
Experimental: High-dose; High-dose YB-1113	Drug: YB-1113; Human umbilical cord tissue-derived mesenchymal stem cells (hUC-MSC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse events (AE)	Reported treatment-related AE and serious adverse events (SAE)	52 weeks

Secondary Outcome Measures

Outcome Measure	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	2, 6, 12, 24, and 52 weeks
Antral follicle counts (AFC)	Changes of AFC numbers from baseline	2, 6, 12, 24, and 52 weeks

Collaborators and Investigators

• Sponsor: Bright Cell, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): December 9, 2026
• Primary Completion (Estimated): January 9, 2028
• Study Completion (Estimated): April 9, 2028

Study Registration Dates

• First Submitted: August 6, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 21, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: YB1113-POI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No