POIPhase 1NCT05494723
Safety and Efficacy of YB-1113 in Treatment of POI
A Phase 1 study testing YB-1113 in people with POI, run by Bright Cell, Inc..
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- POI
- What is being tested?
- YB-1113
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 9 Dec 2026to 9 Apr 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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).
- Conditions
- POI
- Being tested
- YB-1113
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YB-1113Drug
Human umbilical cord tissue-derived mesenchymal stem cells (hUC-MSC)
| Study group | Role | What they receive |
|---|---|---|
| Low-dose | Experimental | Low-dose YB-1113 Receives: Drug: YB-1113 |
| High-dose | Experimental | High-dose YB-1113 Receives: Drug: YB-1113 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (AE)
Reported treatment-related AE and serious adverse events (SAE)
Measured: 52 weeks
Secondary outcomes (3)
Blood anti-Müllerian hormone (AMH) level
Changes of AMH level from baseline
Measured: 2, 6, 12, 24, and 52 weeks
Follicle-stimulating hormone (FSH) and estradiol (E2) levels
Changes of FSH and E2 from baseline
Measured: 2, 6, 12, 24, and 52 weeks
Antral follicle counts (AFC)
Changes of AFC numbers from baseline
Measured: 2, 6, 12, 24, and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start9 Dec 2026 (estimated)
- Primary completion9 Jan 2028 (estimated)
- Study completion9 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for POIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bright Cell, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494723
- Sponsor's protocol ID
- YB1113-POI
- Status last verified
- Dec 2025
- First submitted
- 6 Aug 2022
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of the Safety and Efficacy of YB-1113 in Treatment of Premature Ovarian Insufficiency (POI) Via Intravenous Infusion
- ClinicalTrials.gov ID
- NCT05494723
- Acronym / sponsor ID
- YB1113-POI
- Conditions
- POI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Bright Cell, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2026 (estimated)
- Primary completion
- 9 Jan 2028 (estimated)
- Study completion
- 9 Apr 2028 (estimated)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose | Experimental | Drug: YB-1113Low-dose YB-1113 |
| High-dose | Experimental | Drug: YB-1113High-dose YB-1113 |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YB-1113Human umbilical cord tissue-derived mesenchymal stem cells (hUC-MSC) | Drug | High-dose, Low-dose |
Primary outcome
Incidence of treatment-emergent adverse events (AE)
Time frame: 52 weeks
Reported treatment-related AE and serious adverse events (SAE)
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing YB-1113 in people with POI, run by Bright Cell, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Wang (949-333-3636, jenniferw@brightcellinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (AE) (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.