NCT04435249

ENgineered Tissue Repair of BronchopleUral FiSTula

Phase I/II, Open Label Study to Assess the Safety and Efficacy Autologous Bone Marrow-derived Mesenchymal Stromal Cells Seeded on to Decellularised Airway Scaffold in Subjects with Clinically Significant Bronchopleural Fistula

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Videregen Limited · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

Phase I/II Open-label Study to Assess the Safety and Efficacy of a Novel Tissue Engineered Airway Product, Consisting of Expanded Autologous Bone Marrow (BM) Derived Mesenchymal Stromal Cells (MSC) Seeded on to a Decellularised Allogeneic Patch of an Airway Scaffold in Subjects With Clinically Significant Bronchopleural Fistula.

Detailed description

The proposed clinical trial is a phase I/II open-label study to assess the safety and efficacy of a novel tissue engineered airway product, consisting of expanded autologous Bone Marrow (BM) derived Mesenchymal Stromal Cells (MSC) seeded on to a decellularised allogeneic patch of an airway scaffold in subjects with clinically significant bronchopleural fistula. It is a phase I/II open-label study, which is an uncontrolled pilot in 5 subjects.

Conditions

• Bronchopleural Fistula

Interventions

Type	Name	Description
OTHER	BPF-001	Expanded somatic mesenchymal stromal cells (MSCs) seeded onto a decellularised human tracheal-scaffold

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-03-01
• Completion: 2028-11-01
• First posted: 2020-06-17
• Last updated: 2025-04-01