Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in the Treatment of Primary Ovarian Insufficiency (HS_SW01)

A Phase I/Ⅱ Clinical Trial for HS_SW01 Cells Injection in the Treatment of Primary Ovarian Insufficiency

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Ovarian Insufficiency (Poi)
• Intervention / Treatment: Drug: HS_SW01 cells injection; Drug: HS_SW01 cells injection; Drug: HS_SW01 cells injection

Detailed Description

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
• Enrollment (Estimated): 21
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Voluntarily sign the informed consent form;
2. Age ≥18 to <40 years, with oligomenorrhea or amenorrhea >4 months;
3. Serum baseline FSH >25 U/L (at least two measurements, interval >4 weeks);
4. Have received stable standard treatment for POI, such as ≥3 months of standardized hormone replacement therapy (HRT) with stable hormone levels;
5. No fertility requirement and adherence to strict contraception.

Exclusion Criteria:

1. Individuals with childbearing plans or those who are pregnant.
2. Genetic disorders, chromosomal abnormalities, or genetic defects known to cause premature ovarian insufficiency (POI).
3. Endocrine disorders affecting ovarian function, including polycystic ovary syndrome, hyperprolactinemia, hyperandrogenism, diabetes mellitus, and abnormalities of thyroid or adrenal function.
4. Presence of breast, uterine, or ovarian tumors; known or suspected sex hormone-dependent malignancies; or any other benign or malignant tumors.
5. Primary amenorrhea.
6. Uterine malformations.
7. Iatrogenic or drug-induced ovarian insufficiency.
8. Uncontrolled acute or chronic gynecological inflammation (including endometritis, etc.).
9. Bilateral endometrial thickness ≤8 mm after moderate-to-severe intrauterine adhesion surgery.
10. Complicated with endometriosis.
11. Severe functional impairment of major organs or coagulation disorders.
12. Active venous or arterial thromboembolic disease within the past 6 months.
13. Severe hepatic or renal insufficiency, etc.
14. Vaccination with live or live-attenuated vaccines within 2 months prior to enrollment.
15. Prior treatment with mesenchymal stem cells less than 3 months before enrollment.
16. Uncontrolled hypertension (>150/100 mmHg).

17. Any of the following conditions within 3 months prior to enrollment:

    1. 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;
    2. Receipt of plasma exchange or extracorporeal photopheresis;
    3. Participation in any other interventional clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low dose group; intravenous inject MSCs	Drug: HS_SW01 cells injection; A single dose of 1×10^6 cells/kg of HS_SW01 cells injection will be given by intravenous infusion.; Drug: HS_SW01 cells injection; A single dose of 2×10^6 cells/kg of HS_SW01 cells injection will be given by intravenous infusion.; Drug: HS_SW01 cells injection; A single dose of 3×10^6 cells/kg of HS_SW01 cells injection will be given by intravenous infusion.
Experimental: Medium dose group; intravenous inject MSCs	Drug: HS_SW01 cells injection; A single dose of 1×10^6 cells/kg of HS_SW01 cells injection will be given by intravenous infusion.; Drug: HS_SW01 cells injection; A single dose of 2×10^6 cells/kg of HS_SW01 cells injection will be given by intravenous infusion.; Drug: HS_SW01 cells injection; A single dose of 3×10^6 cells/kg of HS_SW01 cells injection will be given by intravenous infusion.
Experimental: High dose group; intravenous inject MSCs	Drug: HS_SW01 cells injection; A single dose of 1×10^6 cells/kg of HS_SW01 cells injection will be given by intravenous infusion.; Drug: HS_SW01 cells injection; A single dose of 2×10^6 cells/kg of HS_SW01 cells injection will be given by intravenous infusion.; Drug: HS_SW01 cells injection; A single dose of 3×10^6 cells/kg of HS_SW01 cells injection will be given by intravenous infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of DLT	Incidence of dose-limiting toxicities (DLTs) within 28 days following study drug administration.	Within 28 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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 .	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.	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.	Up to Week 24

Collaborators and Investigators

• Sponsor: Shenzhen Huishan Biotechnology Co., Ltd.
• Collaborators: Southern Medical University, China

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 12, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: MSC; Primary Ovarian Insufficiency
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Primary Ovarian Insufficiency
• Other Study ID Numbers: HS_SW01-POI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No