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Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in the Treatment of Primary Ovarian Insufficiency
Sponsor: Shenzhen Huishan Biotechnology Co., Ltd.
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
Conditions
Interventions
HS_SW01 cells injection
A single dose of 1×10\^6 cells/kg of HS\_SW01 cells injection will be given by intravenous infusion.
HS_SW01 cells injection
A single dose of 2×10\^6 cells/kg of HS\_SW01 cells injection will be given by intravenous infusion.
HS_SW01 cells injection
A single dose of 3×10\^6 cells/kg of HS\_SW01 cells injection will be given by intravenous infusion.