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RECRUITING
NCT06574581
PHASE1/PHASE2

ADSCs Therapy in Patients With CTD-ILD

Sponsor: China Medical University Hospital

View on ClinicalTrials.gov

Summary

Connective tissue disease (CTD), an autoimmune and inflammatory disease, usually accompanied by lung interstitial/alveolar inflammation and fibrosis (so called interstitial lung disease, ILD). The prevalence and mortality rate of CTD-ILD increase in recent several years. Although the use of corticosteroids and strong immunosuppressants can improve ILD in some patients with CTD, progressive lung fibrosis which needs lung transplantation and results in respiratory failure, even with mortality is observed. Currently, stem cell therapy is a breakthrough in the treatment of CTD-ILD, and the effective therapy with stem cells for patients with ILD have been reported.

Official title: Allogenic Adipose Tissue Derived-MSCs Therapy in Patients With Connective Tissue Diseases-associated Interstitial Lung Disease(CTD-ILD): Phase I/IIa Clinical Trial

Key Details

Gender

All

Age Range

20 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2024-08-20

Completion Date

2026-05-30

Last Updated

2024-08-28

Healthy Volunteers

No

Interventions

BIOLOGICAL

ADSC01

The initial 3 subjects will receive low-dose AD-MSC (1x10E6 cells/kg) infusion therapy only once; if no adverse events after 4 weeks, the next 4-7 subjects will receive medium-dose AD-MSC (1x10E6 cells/kg) infusion therapy twice; if no adverse events after 4 weeks of the last infusion, the next 8-10 subjects will receive high-dose AD-MSC (1x10E6 cells/kg) infusion therapy three times.

Locations (1)

China Medical University Hospital

Taichung, Taiwan