NCT07535931

A Phase I/Ⅱ Clinical Trial for HS_SW01 Cells Injection in the Treatment of Systemic Sclerosis

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 21 (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 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.

Detailed description

Systemic sclerosis (SSc) is a multisystem connective tissue disease involving the skin and internal organs. It is primarily characterized by chronic inflammation of affected tissues with varying degrees of collagen deposition (fibrosis), as well as peripheral and visceral obliterative vasculopathy. SSc is associated with high morbidity and mortality, particularly in patients with involvement of the lungs, heart, gastrointestinal tract, and kidneys. Scleroderma renal crisis, pulmonary arterial hypertension, and interstitial lung disease are the leading causes of death. Current treatments for SSc primarily focus on delaying disease progression and alleviating symptoms, however, their therapeutic effects are limited. As SSc significantly threatens patients' quality of life and survival, there is an urgent need to explore new therapeutic strategies. Mesenchymal stem cell (MSC) therapy is a novel therapeutic approach that leverages the self-renewal and multidirectional differentiation capabilities of MSCs. When administered to specific sites of tissue injury, MSCs can differentiate into various cell types, thereby exerting therapeutic effects. Human umbilical cord mesenchymal stem cells (hUC-MSCs), a type of multipotent mesenchymal stem cells found in neonatal umbilical cord tissue, exhibit immunomodulatory and immunosuppressive properties, making them an effective and promising potential treatment for systemic sclerosis. 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 stage is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the safety and tolerability of HS\_SW01 cells injection in patients with systemic sclerosis, to further explore its PK, immunogenicity profiles and preliminary efficacy. The Phase II dose-expansion stage is a randomized, double-blind, controlled study designed to evaluate the safety, efficacy, and changes in disease-related biomarkers of HS\_SW01 cells injection in patients with systemic sclerosis. During the Phase I, the trial includes three dose groups: 0.5×10\^6 cells/kg, 1.0×10\^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 systemic sclerosis between 18 and 65 years of age inclusive, who satisfy all the inclusion criteria and do not meet any of the exclusion criteria.

Conditions

• Systemic Sclerosis (SSc)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-04-10
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-04-17
• Last updated: 2026-04-17