Phase I/II Clinical Trial for HS_SW01 Cells Injection in Systemic Sclerosis
Summary
The National Institutes of Health registered a Phase I/II clinical trial (NCT07535931) on ClinicalTrials.gov to evaluate the safety, tolerability, pharmacokinetics, and immunological profile of HS_SW01 human umbilical cord mesenchymal stem cell injection in patients with systemic sclerosis. The single-arm, open-label trial will enroll participants who meet specified inclusion and exclusion criteria following informed consent. No regulatory approvals or compliance deadlines are established by this registration notice.
What changed
ClinicalTrials.gov registered a new Phase I/II clinical trial (NCT07535931) titled 'A Phase I/Ⅱ Clinical Trial for HSSW01 Cells Injection in the Treatment of Systemic Sclerosis.' The trial evaluates HSSW01 human umbilical cord mesenchmymal stem cell injection for safety, tolerability, pharmacokinetics, immunological profile, and preliminary efficacy in systemic sclerosis patients. Participants must meet protocol inclusion/exclusion criteria and sign informed consent before enrollment.
Healthcare providers and clinical investigators involved in systemic sclerosis research should note this trial for awareness. The registration provides no compliance obligations, penalties, or deadlines — it is an informational record of a forthcoming study. Trial sponsors and biopharmaceutical companies developing stem cell therapies for autoimmune conditions may reference this as a benchmark for similar regenerative medicine clinical programs.
Archived snapshot
Apr 18, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
A Phase I/Ⅱ Clinical Trial for HS_SW01 Cells Injection in the Treatment of Systemic Sclerosis
Phase 1 NCT07535931 Kind: PHASE1 Apr 17, 2026
Abstract
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: HSSW01 cells injection, HSSW01 cells injection, HS_SW01 cells injection
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