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Could stem cells restore ovarian function? new trial begins

NCT ID NCT07551895

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a single injection of stem cells from donated umbilical cords in 21 women with primary ovarian insufficiency (early menopause). The goal is to see if the treatment is safe and if it can improve hormone levels. Participants will be monitored for 24 weeks.

What this could mean

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

Active substance
HS_SW01 cells (stem cells from umbilical cord)
What this could lead to
If it works, this could point toward a treatment that restores ovarian function and reduces the need for hormone therapy.
What could go wrong
This is an early phase 1/2 trial with only 21 participants, so results may not apply widely. Stem cell treatments can have unknown long-term risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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 21 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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. Voluntarily sign the informed consent form; 2. Age ≥18 to \<40 years, with oligomenorrhea or amenorrhea \>4 months; 3. Serum baseline FSH \>25 U/L (at least two measurements, interval \>4 weeks); 4. Have received stable standard treatment for POI, such as ≥3 months of standardized hormone replacement therapy (HRT) with stable hormone levels; 5. No fertility requirement and adherence to strict contraception. Exclusion Criteria: 1. Individuals with childbearing plans or those who are pregnant. 2. Genetic disorders, chromosomal abnormalities, or genetic defects known to cause premature ovarian insufficiency (POI). 3. Endocrine disorders affecting ovarian function, including polycystic ovary syndrome, hyperprolactinemia, hyperandrogenism, diabetes mellitus, and abnormalities of thyroid or adrenal function. 4. Presence of breast, uterine, or ovarian tumors; known or suspected sex hormone-dependent malignancies; or any other benign or malignant tumors. 5. Primary amenorrhea. 6. Uterine malformations. 7. Iatrogenic or drug-induced ovarian insufficiency. 8. Uncontrolled acute or chronic gynecological inflammation (including endometritis, etc.). 9. Bilateral endometrial thickness ≤8 mm after moderate-to-severe intrauterine adhesion surgery. 10. Complicated with endometriosis. 11. Severe functional impairment of major organs or coagulation disorders. 12. Active venous or arterial thromboembolic disease within the past 6 months. 13. Severe hepatic or renal insufficiency, etc. 14. Vaccination with live or live-attenuated vaccines within 2 months prior to enrollment. 15. Prior treatment with mesenchymal stem cells less than 3 months before enrollment. 16. Uncontrolled hypertension (\>150/100 mmHg). 17. Any of the following conditions within 3 months prior to enrollment: 1. Major trauma or major surgery (including joint surgery), or anticipated need for major surgery during the study period, which in the investigator's opinion poses unacceptable risk to the participant; 2. Receipt of plasma exchange or extracorporeal photopheresis; 3. Participation in any other interventional clinical trial.

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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 official record

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More trials for these conditions

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