NCT06514378

Safety of Endobronchial Mesenchymal Stromal Cells in the Treatment of Chronic Lung Allograft Dysfunction

An Open Label, Randomised, Controlled Clinical Trial to Asses the Safety of Endobronchial Administration of Allogneic Mesenchymal Stromal Cells in Patients With Lung Trasplant Chronic Rejection: Endosclad Study.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Instituto De Investigación Sanitaria Puerta De Hierro-Segovia De Arana · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Lung transplantation is the only therapeutic alternative for more and more patients with respiratory diseases in their most advanced stages. The most limiting factor to achieve long term survival si chronic lung allograft dysfunction, a multifactorial disease without an effective treatment. The immunomodulatory capacity of mesenchymal stem cells enables them to be a potential therapeutic agent for this condition. The objective of this study is to assess the safety of endobronchial administration of allogeneic MSCs in patients with chroniclung allograft dysfunction.

Conditions

• Chronic Lung Disease
• Lung Transplant Rejection

Interventions

Type	Name	Description
BIOLOGICAL	Mesenchymal stem cells	Endobronchial administration of 10⁶ MSCs/kg in each transplanted lung, 4 weeks apart.

Timeline

• Start date: 2023-09-19
• Primary completion: 2025-12-31
• Completion: 2026-03-31
• First posted: 2024-07-23
• Last updated: 2024-07-26

Locations

1 site across 1 country: Spain