NCT07534644

A Phase I/Ⅱ Clinical Trial for HS_SW01 Cells Injection in the Treatment of Ankylosing Spondylitis

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Shenzhen Huishan Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 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.

Detailed description

This clinical trial is a multicenter Phase I/II clinical trial, which includes two stages: Phase I dose-escalation and Phase II dose-expansion. The Phase I dose-escalation stage adopts a single-arm design and aims to evaluate the safety, tolerability and preliminary efficacy of HS\_SW01 cells injection in patients with Ankylosing Spondylitis. The Phase II dose-expansion stage is a randomized, double-blind, controlled study designed to evaluate the safety and efficacy of HS\_SW01 cells injection in patients with Ankylosing Spondylitis. During the Phase I, the trial includes three dose groups: 1.0×10\^6 cells/kg, 2.0×10\^6 cells/kg and 2.0×10\^6 cells/kg. Using a "3+3" dose-escalation design, each dose group will enroll 4 to 7 subjects in sequential order from the lowest to the highest dose level. Eligible participants are patients with Ankylosing Spondylitis between 18 and 65 years of age inclusive, who satisfy all the inclusion criteria and do not meet any of the exclusion criteria.

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	HS_SW01 cells injection	HS\_SW01 cells injection will be given as a single intravenous infusion.

Timeline

• Start date: 2026-04-10
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-04-16
• Last updated: 2026-04-16