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

NCT07551895 | Not Yet Recruiting Phase 1

• 1 other identifier: HS_SW01-POI
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Primary Ovarian Insufficiency (Poi)

Keywords

Primary Ovarian Insufficiency; MSC

Outcome Measures

Primary Outcomes (1)

• The incidence of DLT

  Incidence of dose-limiting toxicities (DLTs) within 28 days following study drug administration.

  Within 28 Days

Secondary Outcomes (7)

• 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.

  Baseline, Week 4, Week 12, Week 24

• 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.

  Baseline, Week 4, Week 12, Week 24

• Changes of the Antral Follicle Counting (AFC) from baseline.

  Baseline, Week 4, Week 12, Week 24

Study Arms (3)

Low dose group

EXPERIMENTAL

intravenous inject MSCs

Drug: HS_SW01 cells injection

Medium dose group

EXPERIMENTAL

intravenous inject MSCs

Drug: HS_SW01 cells injection

High dose group

EXPERIMENTAL

intravenous inject MSCs

Drug: HS_SW01 cells injection

Interventions

HS_SW01 cells injection DRUG

A single dose of 1×10\^6 cells/kg of HS\_SW01 cells injection will be given by intravenous infusion.

Low dose group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Shenzhen Huishan Biotechnology Co., Ltd.: lead
• Southern Medical University, China: collaborator

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 27, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share