Phase Ⅰ/Ⅱa Trial Evaluating Intravenous hUC-MSCs Injection for Safety, Tolerability and Efficacy in Patients With POI

August 19, 2026 updated by: Shenzhen Wingor Biotechnology Co., Ltd.

Phase Ⅰ/Ⅱa Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Intravenous Injection of Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSCs) in Patients With Premature Ovarian Insufficiency (POI)

A Phase I/IIa clinical study evaluating the safety, tolerability and efficacy of intravenously administered human umbilical cord mesenchymal stem cell (hUC-MSCs) injection in patients with premature ovarian insufficiency (POI).

The primary objective of the Phase I dose-escalation stage is to assess the safety and tolerability of intravenous infusion of hUC-MSCs injection for the treatment of POI, and to determine the recommended phase II dose (RP2D) for the Phase IIa clinical trial.

The primary objective of the Phase IIa dose-expansion stage is to evaluate the efficacy of intravenous infusion of hUC-MSCs injection in POI treatment, and to generate data to support pivotal/confirmatory clinical trials.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Premature ovarian insufficiency (POI) is defined as ovarian dysfunction occurring in women before the age of 40, which is mainly characterized by menstrual abnormalities (amenorrhea, oligomenorrhea or polymenorrhea), elevated gonadotropin levels (FSH > 25 U/L), and fluctuating decline in estrogen levels. The incidence of POI is age-specific: 1 in 250 women develops POI before 35 years of age, and 1 in 100 women develops POI before 40 years of age. The incidence rate of POI in China is 2.8%, showing an upward trend year by year with a younger onset age.

hormone replacement therapy (HRT) relieves symptoms caused by low estrogen through estrogen supplementation. Sequential estrogen-progestogen therapy is recommended for POI patients with an intact uterus. Since patients with POI require long-term HRT, natural or nearly natural estrogens and progestogens can be selected to minimize adverse effects on the mammary gland, metabolism, cardiovascular system and other systems. Nevertheless, HRT still increases the risks of breast cancer, heart disease and stroke.

Studies have demonstrated that mesenchymal stem cells can home to ovarian stroma, regulate the balance of Th1/Th2 cytokines and the expression of endometrial natural killer cells, alleviate inflammatory responses, inhibit apoptosis of ovarian granulosa cells and reduce ovarian interstitial fibrosis, thereby improving the ovarian microenvironment. Meanwhile, these cells can secrete growth factors including VEGF, IGF-1 and HGF, promote proliferation of various ovarian cells and angiogenesis, repair ovarian structure and restore ovarian ovarian function. This study aims to evaluate the safety, tolerability and efficacy of intravenously administered hUC-MSCs in the treatment of patients with POI.

Study Type

Interventional

Enrollment (Estimated)

59

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 18 to 40 years at the time of signing the informed consent form (exclusive of the boundary values);
  2. Meet the diagnostic criteria specified in the Expert Consensus on Clinical Diagnosis and Treatment of Premature Ovarian Insufficiency (2023 Edition): oligomenorrhea (menstrual cycle longer than 35 days) or amenorrhea for more than 4 months, with basal serum follicle-stimulating hormone (FSH) > 25 U/L (tested on Days 2-4 of the menstrual cycle or during amenorrhea, at least twice with an interval of ≥4 weeks);

  3. Satisfy one of the following two criteria:

    1. Total number of antral follicles (AFC) with a diameter of 2-10 mm in bilateral ovaries < 5;
    2. Serum anti-Müllerian hormone (AMH) ≤ 7.85 pmol/L (equivalent to 1.1 ng/mL);
  4. Have received standardized hormone replacement therapy (HRT) at a stable dose for ≥3 months prior to drug administration with stable hormone levels, and maintain stable HRT per medical advice throughout the trial (within 24 weeks after enrollment);
  5. Have no fertility requirements;
  6. Agree to use effective contraceptive measures throughout the trial period (such as complete abstinence, condoms, cervical caps plus spermicides, intrauterine devices, etc.);
  7. Negative serum β-hCG test result during the screening period (to rule out pregnancy);
  8. Fully understand the trial information and sign the informed consent form.

Exclusion Criteria:

  1. Subjects with primary amenorrhea;
  2. Subjects with thyroid disorders (hypothyroidism/hyperthyroidism or thyroid malignant tumors) or resistant ovary syndrome (ROS);
  3. Subjects with abnormal female karyotypes (e.g., Turner syndrome, Fragile X syndrome);
  4. Positive serology tests (HBV antibody, HCV antibody, HIV antibody, syphilis). Exceptions: HBV carriers, patients with stable HBV after drug treatment (HBV DNA titer ≤500 IU/mL or copies <1000 copies/mL), and patients with cured HCV (negative HCV RNA test) may be enrolled if deemed eligible by the investigator;
  5. Subjects receiving or planning to use the following medications during the trial: oral or systemic corticosteroids, danazol, anticoagulants, Chinese herbal medicines or botanical supplements that may affect hormone levels or ovarian function;
  6. History of hypersensitivity to human serum albumin;
  7. Pregnant or breastfeeding subjects;
  8. Participation in another clinical trial within the past 3 months, or receipt of other cell therapies (excluding blood transfusion);
  9. History of malignant tumors;
  10. Subjects with contraindications or cautions for estrogen use, including known or suspected breast cancer, endometrial cancer, other known or suspected sex hormone-dependent malignancies, active venous or arterial thromboembolic diseases within the last 6 months, undiagnosed abnormal genital bleeding, severe hepatic or renal insufficiency [serum aspartate aminotransferase (AST) >3×ULN, serum alanine aminotransferase (ALT) >3×ULN, estimated glomerular filtration rate (eGFR) <60 mL/min], etc.;
  11. Uncontrolled diabetes, hypertension (>150/100 mmHg), heart disease, etc.;
  12. Any other conditions judged by the investigator to render the subject unsuitable for participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase I, Dose Cohort 1
Human Umbilical Cord Mesenchymal Stem Cells Injection
Drug: hUC-MSCs Injection (Phase I)
hUC-MSCs Injection, administered via intravenous infusion as a single dose on D0.
Other Names:
  • hUC-MSCs
Experimental: Phase I, Dose Cohort 2
Human Umbilical Cord Mesenchymal Stem Cells Injection
Drug: hUC-MSCs Injection (Phase I)
hUC-MSCs Injection, administered via intravenous infusion as a single dose on D0.
Other Names:
  • hUC-MSCs
Experimental: Phase I, Dose Cohort 3
Human Umbilical Cord Mesenchymal Stem Cells Injection
Drug: hUC-MSCs Injection (Phase I)
hUC-MSCs Injection, administered via intravenous infusion as a single dose on D0.
Other Names:
  • hUC-MSCs
Experimental: Phase IIa, Medium-Dose Cohort
Human Umbilical Cord Mesenchymal Stem Cells Injection
Drug: hUC-MSCs Injection (Phase IIa)
hUC-MSCs Injection, 3 infusions in total, dosing interval ≥7 days.
Other Names:
  • hUC-MSCs
Experimental: Phase IIa, High-Dose Cohort
Human Umbilical Cord Mesenchymal Stem Cells Injection
Drug: hUC-MSCs Injection (Phase IIa)
hUC-MSCs Injection, 3 infusions in total, dosing interval ≥7 days.
Other Names:
  • hUC-MSCs
Placebo Comparator: Phase IIa, Placebo Cohort
Multiple Electrolytes Injection
Drug: Placebo
3 infusions in total, dosing interval ≥7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase I : Incidence and number of subjects with treatment-emergent adverse events and serious adverse events.
Time Frame: 48 weeks
In this Phase I stage, safety is the primary endpoint. Types, frequencies, severities and causal relationships of all adverse events (AEs) and serious adverse events (SAEs) occurring from the first administration of study drug to the end of safety follow-up (48 weeks), assessed in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 6.0; together with the proportion of adverse events judged by the investigator to be related to the study drug.
48 weeks
Phase II ：FSH
Time Frame: at Week 24 post-treatment
To evaluate the changes from baseline in serum follicle-stimulating hormone (FSH) levels at Week 24 post-treatment.
at Week 24 post-treatment
Phase II ：E2
Time Frame: at Week 24 post-treatment
To evaluate the changes from baseline in serum festradiol (E2) levels at Week 24 post-treatment.
at Week 24 post-treatment
Phase II ：AMH
Time Frame: at Week 24 post-treatment
To evaluate the changes from baseline in serum anti-Müllerian hormone (AMH) levels at Week 24 post-treatment.
at Week 24 post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase I: FSH
Time Frame: 48 weeks
To evaluate the changes from baseline in serum follicle-stimulating hormone (FSH) levels.
48 weeks
Phase I ：E2
Time Frame: 48 weeks
To evaluate the changes from baseline in serum estradiol (E2) levels
48 weeks
Phase I : AMH
Time Frame: 48 weeks
To evaluate the changes from baseline in serum anti-Müllerian hormone (AMH) levels.
48 weeks
Phase II: Incidence and number of subjects with treatment-emergent adverse events and serious adverse events.
Time Frame: 48 weeks
In this Phase II stage, safety is the secondary endpoint. Types, frequencies, severities and causal relationships of all adverse events (AEs) and serious adverse events (SAEs) occurring from the first administration of study drug to the end of safety follow-up (48 weeks), assessed in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 6.0; together with the proportion of adverse events judged by the investigator to be related to the study drug.
48 weeks
Phase I/II: AFC
Time Frame: 48 weeks
Changes from baseline in antral follicle count (AFC) by transvaginal ultrasound.
48 weeks
Phase I/II: endometrial thickness
Time Frame: 48 weeks
Changes from baseline in endometrial thickness measured by transvaginal ultrasound.
48 weeks
Phase I/II: menstrual recovery status
Time Frame: 48 weeks
Menstrual recovery status will be assessed via patient inquiry at each visit.
48 weeks
Phase I/II:Modified Kupperman Index
Time Frame: 48 weeks

To evaluate the changes in the Modified Kupperman Index from baseline across all post-baseline follow-up visits.

Modified Kupperman Index will be assessed through physician interview.The total score ranges from 0 to 63 points. Total score stratification: >30 points indicates severe symptoms, 16-30 points moderate symptoms, 6-15 points mild symptoms, and <6 points normal status.
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Wingor Biotechnology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2026

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

August 2, 2029

Study Registration Dates

First Submitted

July 27, 2026

First Submitted That Met QC Criteria

August 19, 2026

First Posted (Actual)

August 20, 2026

Study Record Updates

Last Update Posted (Actual)

August 20, 2026

Last Update Submitted That Met QC Criteria

August 19, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WG108-POI-I/IIa

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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