Phase IIIa Study of Allogenic Adipose-Derived Stem Cell Therapy for Treating Connective Tissue Disease-Associated Interstitial Lung Disease in Adults

What this Trial Is About

Connective tissue disease CTD is an autoimmune and inflammatory condition often linked with lung inflammation and scarring called interstitial lung disease ILD. The number of people affected and deaths from CTD-ILD have increased recently. While corticosteroids and strong immunosuppressants help some patients, progressive lung fibrosis can lead to respiratory failure and may require lung transplantation. Stem cell therapy is emerging as a new approach for treating CTD-ILD, with promising reports using stem cells for ILD patients. This Phase IIIa open-label trial involves intravenous transfusion of allogenic adipose tissue-derived mesenchymal stem cells AD-MSC in 10 patients with refractory or rapidly progressive ILD due to CTD. The first 3 participants will receive a low-dose infusion once if no adverse effects occur after 4 weeks, the next 4 to 7 participants will receive medium-dose infusions twice if still no adverse effects after 4 weeks, the last 2 to 3 participants will receive high-dose infusions three times. The goal is to improve outcomes and find the best dose of AD-MSC therapy. Participants will undergo initial evaluations before treatment, receive the stem cell infusions during admission, and then be followed up for safety and effectiveness for 48 weeks after the last infusion. Researchers will monitor safety throughout and assess lung function and other health indicators to evaluate treatment impact. The total study period includes treatment and nearly a year of post-infusion observation to track outcomes and any adverse effects.

ADSCs Therapy in Patients With CTD-ILD