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Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in the Treatment of Systemic Sclerosis

NCT07535931 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-04-21

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety and tolerability of human umbilical cord mesenchymal stem cell injection(HS\_SW01 Cells injection) in patients with systemic sclerosis, and to further explore its pharmacokinetics(PK), immunological profile and preliminary efficacy.

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

  • Systemic Sclerosis (SSc)

Interventions

DRUG

HS_SW01 cells injection

A single dose of 0.5×10⁶ cells/kg of HS\_SW01 cells injection will be given by intravenous infusion.

DRUG

HS_SW01 cells injection

A single dose of 1×10⁶ cells/kg of HS\_SW01 cells injection will be given by intravenous infusion.

DRUG

HS_SW01 cells injection

A single dose of 2×10⁶ 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
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-10
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 NCT07535931 on ClinicalTrials.gov