Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06058091
PHASE1/PHASE2

RY_SW01 Cell Injection Therapy in Systemic Sclerosis

Sponsor: Jiangsu Renocell Biotech Company

View on ClinicalTrials.gov

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.

Official title: A Multicenter Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of RY_SW01 Cell Injection Therapy in Systemic Sclerosis

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

81

Start Date

2023-09-22

Completion Date

2035-12-31

Last Updated

2024-01-18

Healthy Volunteers

No

Interventions

DRUG

RY_SW01 cell injection

Administer basic treatment with an injection of RY\_SW01 cell solution

DRUG

Basic treatment

Basic treatment for SSc

Locations (1)

Department of Rheumatology and Immunology, Nanjing Drum Tower Hospital, the Affiliated Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China