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NOT YET RECRUITING
NCT07551895
PHASE1/PHASE2

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

Sponsor: Shenzhen Huishan Biotechnology Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

21

Start Date

2026-04-15

Completion Date

2027-12-31

Last Updated

2026-04-27

Healthy Volunteers

No

Interventions

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.