NCT06823063

Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cells (IxCell hUC-MSC-P) in the Treatment of CTD-ILD

A Phase I Clinical Trial to Evaluate the Safety and Tolerability of a Single Dose of Human Umbilical Cord Mesenchymal Stem Cell Injection (IxCell hUC-MSC-P) in Patients With Connective Tissue Disease-associated Interstitial Lung Disease

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Shanghai IxCell Biotechnology Co., LTD · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and tolerability of IxCell hUC-MSC-P in the treatment of patients with connective tissue disease-related interstitial lung disease. To evaluate the efficacy, pharmacokinetics and immunogenicity of IxCell hUC-MSC-P in the treatment of connective tissue disease-associated interstitial lung disease (CTD-ILD).

Detailed description

Mesenchymal stem cells (MSCs) are a kind of adult stem cells, which express CD73, CD40 and CD105 on the cell surface, but not CD34, CD45 and HLA-DR. They can self-renew in vitro culture environment and have the ability to differentiate into bone, adipose and chondrocytes. Because of its anti-inflammatory, immunomodulatory and natural regenerative functions, it has become a potential therapeutic drug to control lung immune dysfunction and inflammatory response. MSCs can regulate the microenvironment of injured tissues by secreting anti-inflammatory factors and exert immunomodulatory ability through cell interaction. Firstly, MSCs can directly inhibit the proliferation of T cells, thereby reducing the number of T cells in the inflammatory site. Secondly, MSCs can also suppress T cell responses through paracrine effects. MSCs can secrete soluble immunosuppressive factors such as prostaglandin E2 (PEG2), transforming growth factor β (TGF-β), indole2, 3-dioxygenase (IDO) and nitric oxide (NO) to inhibit the ongoing T cell inflammatory response and promote T cell apoptosis. Thirdly, MSCs can attenuate the antigen-presenting ability of dendritic cells (DCs) by inhibiting DCS; Fourth, MSC-induced DCs showed a tolerogenic phenotype, which promoted the transformation of inflammatory M1 macrophages into immunosuppressive M2 macrophages. Fifth, in the manner described above, MSCs reduce the production of inflammatory factors (TNF-α, IL-1β, and IL-12) in DC cells and M1 macrophages, promote the production of anti-inflammatory factors IL-10 and TGF-β, and promote tissue repair and regeneration capacity. At the same time, immunotolerant DCs and M2 macrophages induce MSCs to produce human leukocyte antigen (HLA) G5, which promotes MSCS-induced Treg cells to form an anti-immune environment around the injured lung tissue. The development of CTD-ILD is accompanied by chronic inflammation, and the use of MSCs can alleviate this inflammatory response. Some animal experiments and in vitro culture studies have also shown that MSCs can differentiate into alveolar epithelial cells and have potential regenerative treatment ability for lung diseases. By routine intravenous infusion, MSCs can be captured by the pulmonary vasculature and facilitate the treatment of lung injury. According to the above immunomodulatory and anti-inflammatory functions of MSCs, MSCs therapy can theoretically inhibit the inflammatory response of CTD-ILD and block or even reverse the process of pulmonary fibrosis in patients.

Conditions

• CTD-ILD

Interventions

Type	Name	Description
BIOLOGICAL	MSC	a single injection dose i.v.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-10-30
• Completion: 2026-12-31
• First posted: 2025-02-12
• Last updated: 2025-02-14

Locations

1 site across 1 country: China