Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in the Treatment of Primary Ovarian Insufficiency

Starting soon · Phase 1/Phase 2

Conditions studied: Primary Ovarian Insufficiency (Poi)

In brief

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.

Key facts

Study ID

NCT07551895

Run by

Shenzhen Huishan Biotechnology Co., Ltd.

People needed

21

Starts

2026-04-15

Expected to finish

2027-12-31

Last updated by the study team

2026-04-27

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Uncontrolled acute or chronic gynecological inflammation (including endometritis, etc.).
• Bilateral endometrial thickness ≤8 mm after moderate-to-severe intrauterine adhesion surgery.
• Complicated with endometriosis.
• Severe functional impairment of major organs or coagulation disorders.
• Active venous or arterial thromboembolic disease within the past 6 months.
• Severe hepatic or renal insufficiency, etc.
• Vaccination with live or live-attenuated vaccines within 2 months prior to enrollment.
• Prior treatment with mesenchymal stem cells less than 3 months before enrollment.
• Uncontrolled hypertension (>150/100 mmHg).
• Any of the following conditions within 3 months prior to enrollment:
• 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;
• Receipt of plasma exchange or extracorporeal photopheresis;
• Participation in any other interventional clinical trial.

Full record on ClinicalTrials.gov

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