Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in the Treatment of Primary Ovarian Insufficiency (NCT07551895) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in the Treatment of Primary Ovarian Insufficiency
21 participantsStarted 2026-04-15
Plain-language summary
The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of human umbilical cord mesenchymal stem cell injection (HS\_SW01 cells injection) in patients with Primary Ovarian Insufficiency (POI).
Participants will be required to sign the informed consent form and will only be assigned to the study and enrolled after undergoing a series of tests and meeting the inclusion and exclusion criteria of the protocol.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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Inclusion criteria
✓. Voluntarily sign the informed consent form;
✓. Age ≥18 to \<40 years, with oligomenorrhea or amenorrhea \>4 months;
✓. Serum baseline FSH \>25 U/L (at least two measurements, interval \>4 weeks);
✓. Have received stable standard treatment for POI, such as ≥3 months of standardized hormone replacement therapy (HRT) with stable hormone levels;
✓. No fertility requirement and adherence to strict contraception.
Exclusion criteria
✕. Individuals with childbearing plans or those who are pregnant.
✕. Genetic disorders, chromosomal abnormalities, or genetic defects known to cause premature ovarian insufficiency (POI).
✕. Endocrine disorders affecting ovarian function, including polycystic ovary syndrome, hyperprolactinemia, hyperandrogenism, diabetes mellitus, and abnormalities of thyroid or adrenal function.
✕. Presence of breast, uterine, or ovarian tumors; known or suspected sex hormone-dependent malignancies; or any other benign or malignant tumors.
✕. Primary amenorrhea.
✕. Uterine malformations.
✕. Iatrogenic or drug-induced ovarian insufficiency.