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

NCT07551895 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-04-27

No results posted yet for this study

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)

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.

Sponsors & Collaborators

  • Southern Medical University, China

    collaborator OTHER

  • Shenzhen Huishan Biotechnology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2027-12-31
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07551895 on ClinicalTrials.gov