Human amniotic mesenchymal stem cell treatment for premature ovarian insufficiency

A Randomized, Open-label, Parallel-controlled Clinical Study of Amniotic Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency

This trial will test whether an intravenous infusion of human amniotic mesenchymal stem cells combined with standard hormone therapy can help women under 40 with premature ovarian insufficiency.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 20 Years to 40 Years
• Sex: Female
• Sponsor: Changhai Hospital (other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07115082 on ClinicalTrials.gov

What this trial studies

This Phase 1/2 interventional trial compares standard oral hormone replacement (Climen) alone versus Climen plus an intravenous infusion of human amniotic mesenchymal stem cells (hA-MSCs). Participants are women aged 20–40 with documented premature ovarian insufficiency and elevated FSH, who are followed every two weeks after infusion for safety monitoring and hormone measurements. The primary focus is safety, with secondary observations of hormone levels and signs of follicular growth to provide an initial signal of effectiveness. The trial uses a control group receiving conventional hormone therapy to contextualize any changes seen after stem cell infusion.

Who should consider this trial

Good fit: Ideal candidates are women aged 20–40 with oligo/amenorrhea for at least 4 months, elevated FSH >25 IU/L on two occasions, a normal karyotype, no recent stem-cell or hormone therapy, and willingness to provide informed consent.

Not a fit: Patients with genetic or chromosomal causes of POI (for example Turner syndrome), active gynecologic tumors, prior ovariectomy, significant comorbidities, or who cannot attend follow-up visits are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the treatment could restore ovarian hormone function and promote follicle growth, potentially improving menstrual regularity and fertility prospects for affected women.

How similar studies have performed: Early animal studies and small human case series using mesenchymal stem cells have shown promising signs of restored ovarian function, but robust randomized evidence remains limited.

Eligibility criteria

Inclusion Criteria:

1. The intention of pregnant women aged \>= 20 and \< 40, with normal karyotype;
2. Oligo/amenorrhea for at least 4 months;
3. Elevated FSH level \>25 IU/l on two occasions \>4 weeks apart;
4. Without a history of stem cell therapy and no growth hormone and/or estrogen and progesterone therapy within the previous 3 months;
5. Voluntary participation in the study with signed informed consent;

Exclusion Criteria:

1. Unable to follow the treatment observation process required by the trial;
2. Genetic diseases, chromosomal abnormalities, and genetic deficiency that clearly cause premature ovarian insufficiency/premature ovarian failure;
3. With breast, uterine, ovarian tumors, or any other benign or malignant tumors;
4. Allergic history to drugs or any other things;
5. Presence of genetic disorders such as Turner's syndrome, congenital malformations of the reproductive organs.
6. Have undergone ovariectomy or have organic gynaecological diseases.
7. Presence of other gynaecological endocrine diseases such as polycystic ovary syndrome.
8. Severe functional impairment of vital organs.
9. High risk factors for venous thromboembolism and abnormalities in coagulation mechanisms.
10. Attending doctor considers inappropriate to take part in.

Where this trial is running

Shanghai

• Shanghai Changhai Hospital — Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Hongli Yan PhD, Professor, Reproductive Medici

Conditions: Premature Ovarian Insufficiency, hA-MSCs, Premature ovarian insufficiency