Could stem cells restore ovarian function? new trial begins
NCT ID NCT07551895
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 21 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 40 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.