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

NCT06489652 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-07-08

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Jiangsu Renocell Biotech Company

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2025-05-31
Completion
2027-05-31

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06489652 on ClinicalTrials.gov