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.
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;
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.
Parallel
HS_SW01 cells injection
DrugA single dose of 1×10\^6 cells/kg of HS\_SW01 cells injection will be given by intravenous infusion.
HS_SW01 cells injection
DrugA single dose of 2×10\^6 cells/kg of HS\_SW01 cells injection will be given by intravenous infusion.
HS_SW01 cells injection
DrugA single dose of 3×10\^6 cells/kg of HS\_SW01 cells injection will be given by intravenous infusion.
The incidence of DLT
Incidence of dose-limiting toxicities (DLTs) within 28 days following study drug administration.
Changes of the Anti-Müllerian hormone (AMH) serum level from baseline.
Evaluate the AMH serum level by blood sampling at baseline and at Week 4, Week 12 and Week 24 after administration to assess changes of the Anti-Müllerian hormone (AMH) serum level from baseline.
Changes of the Follicle Stimulating Hormone (FSH) serum level from baseline.
Evaluate the FSH serum level by blood sampling at baseline and at Week 4, Week 12 and Week 24 after administration to assess changes of the Follicle Stimulating Hormone (FSH) serum level from baseline.
Changes of Luteinizing Hormone (LH) serum level from baseline.
Evaluate the LH serum level by blood sampling at baseline and at Week 4, Week 12 and Week 24 after administration to assess changes of Luteinizing Hormone (LH) serum level from baseline.
Changes of the Estradiol (E2) serum level from baseline.
Evaluate the E2 serum level by blood sampling at baseline and at Week 4, Week 12 and Week 24 after administration to assess changes of the Estradiol (E2) serum level from baseline.
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Shenzhen Huishan Biotechnology Co., Ltd.
Lead sponsor
Southern Medical University, China
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
