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.
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. This trial consists of a Phase I dose-escalation stage and a Phase II dose-expansion stage. Phase I is a randomized, double-blind, placebo-controlled design in which all participants receive background therapy plus a single intravenous infusion of HS\_SW01 cells injection (1.0×10\^6 cells/kg, 2.0×10\^6 cells/kg, 3.0×10\^6 cells/kg) or placebo, with 4-7 participants per dose group. A "3+3" dose-escalation design is used to evaluate safety, tolerability, pharmacokinetics, and immunogenicity across the three dose groups. In Phase II, the optimal biological dose (OBD) identified from the Phase I escalation study will serve as the recommended Phase II dose (RP2D) to preliminarily assess efficacy while continuing safety monitoring, providing a basis for subsequent clinical trials. Eligible participants are patients with POI aged ≥18 to \<40 years who meet all inclusion criteria and none of the exclusion criteria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
21
A single dose of 1×10\^6 cells/kg of HS\_SW01 cells injection will be given by intravenous infusion.
A single dose of 2×10\^6 cells/kg of HS\_SW01 cells injection will be given by intravenous infusion.
A 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.
Time frame: Within 28 Days
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.
Time frame: Baseline, Week 4, Week 12, Week 24
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.
Time frame: Baseline, Week 4, Week 12, Week 24
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.
Time frame: Baseline, Week 4, Week 12, Week 24
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.
Time frame: Baseline, Week 4, Week 12, Week 24
Changes of the Antral Follicle Counting (AFC) from baseline.
Evaluate the Antral Follicle Counting (AFC) by sonography at baseline and at Week 4, Week 12 and Week 24 after administration to assess Changes of the Antral Follicle Counting (AFC) from baseline .
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Time frame: Baseline, Week 4, Week 12, Week 24
Changes of the Ovarian Volume (OV) from baseline.
Evaluate the Ovarian Volume (OV) by sonography at baseline and at Week 4, Week 12 and Week 24 after administration to assess Changes of the Ovarian Volume (OV) from baseline.
Time frame: Baseline, Week 4, Week 12, Week 24
Changes of the menstrual function indicators from baseline.
Menstrual function indicators will be recorded via patient diaries or visit questionnaires to evaluate the recovery of menstruation following treatment. The form includes the date of menstrual onset, duration of menstruation (in days), menstrual regularity (regular/irregular; regular defined as cycle fluctuation ≤7 days), and associated symptoms (dysmenorrhea/other, with descriptive notes).Menstrual blood loss will be assessed using the Pictorial Blood Loss Assessment Chart (PBAC), which records, for each menstrual cycle, the type and number of sanitary products used daily, the frequency of clots passed into the toilet, and the total menstrual blood loss (in mL). Menstrual function recovery is defined as meeting all of the following criteria: （1）At least two consecutive cycles of menstrual bleeding after treatment discontinuation;（2）Cycle length restored to 21-35 days;（3）Menstrual blood volume returned to pre-illness levels compared with the subject's own baseline.
Time frame: Up to Week 24