Ignite Creation Date:
2024-07-17 @ 10:44 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489652
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-28
Brief Title:
89Zr-Oxine-RY_SW01 Cell Injection for the Treatment of Systemic Sclerosis
Sponsor:
Jiangsu Renocell Biotech Company
Organization:
Jiangsu Renocell Biotech Company
Study Overview
Official Title:
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
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 10mRSS30 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None