Can umbilical cord stem cells revive failing ovaries?

NCT ID NCT07775391

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial is testing whether infusions of stem cells from human umbilical cord tissue can safely help women with premature ovarian insufficiency (POI), a condition where the ovaries stop working before age 40, leading to irregular periods and fertility challenges. The study involves two phases: first, to find a safe dose, and second, to see if the treatment improves hormone levels and ovarian function. Participants will receive either the stem cell infusion or a placebo, and their progress will be tracked over several months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Human umbilical cord mesenchymal stem cells (hUC-MSCs) given by intravenous infusion
What this could lead to
If successful, this could offer a new way to restore ovarian function and fertility in women with premature ovarian insufficiency, potentially reducing the need for hormone replacement therapy.
What could go wrong
This is an early-stage trial (Phase I/IIa) with a small number of participants, so safety and effectiveness are not yet proven. There is also a risk that the stem cells may not produce the desired effect or could cause side effects.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 59 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100730, China

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