A Phase I/Ⅱ Clinical Trial for Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in the Treatment of Ankylosing Spondylitis

Sponsor
Shenzhen Huishan Biotechnology Co., Ltd.
Study ID
NCT07534644
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • HS_SW01 cells injection — DRUG
    HS\_SW01 cells injection will be given as a single intravenous infusion.

Study Details

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 Ankylosing Spondylitis. 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.

Key Dates

Start date
Apr 10, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: intravenous inject MSCs
    The trial was divided into three dose groups： Low-dose group: 1.0×10\^6 cells/kg; Medium-dose group: 2.0×10\^6 cells/kg; High-does group: 3.0×10\^6 cells/kg

Primary Outcome Measure

The incidence of DLT [ Time Frame: Within 28 Days ]

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