NCT06489652

89Zr-Oxine-RY_SW01 Cell Injection for the Treatment of Systemic Sclerosis

Phase I Clinical Study of in Vivo Distribution and Metabolic Kinetic Characterization of 89Zr-Oxine-RY_SW01 Cell Injection for the Treatment of Systemic Sclerosis

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Jiangsu Renocell Biotech Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Systemic sclerosis (SSc) tends to progress to involve multiple vital organs within 5 years of diagnosis, significantly impacting patient prognosis and survival. Clinical indications suggest that early intervention is more favorable for long-term outcomes in patients. Although guidelines recommend various drugs for symptomatic treatment, there is currently no standard therapy or effective medication to slow the progression of the disease. Therefore, for patients with diffuse SSc, as defined by a skin score of 10≤mRSS≤30 points, who have been treated with at least two therapies, including steroids, immunosuppressive agents, biologics, etc., within 5 years of diagnosis, the applicant intends to develop a drug that can both modulate the immune system and counteract fibrosis. The goal is to provide long-term benefits to patients through early intervention.

Conditions

• Systemic Sclerosis

Interventions

Type	Name	Description
DRUG	89Zr-Oxine-RY_SW01 Cell Injection	Biodistribution and metabolic kinetic characterization of zirconium-labeled cells in vivo for the treatment of systemic sclerosis by intravenous infusion of 89Zr-Oxine-RY\_SW01 cells injection

Timeline

• Start date: 2024-06-30
• Primary completion: 2025-05-31
• Completion: 2027-05-31
• First posted: 2024-07-08
• Last updated: 2024-07-08