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ENgineered Tissue Repair of BronchopleUral FiSTula

NCT04435249 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2025-04-01

No results posted yet for this study

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.

Conditions

  • Bronchopleural Fistula

Interventions

OTHER

BPF-001

Expanded somatic mesenchymal stromal cells (MSCs) seeded onto a decellularised human tracheal-scaffold

Sponsors & Collaborators

  • Cell Therapy Catapult

    collaborator OTHER

  • Papworth Hospital NHS Foundation Trust

    collaborator OTHER_GOV

  • Royal Free Hospital NHS Foundation Trust

    collaborator OTHER

  • Videregen Limited

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2027-03-31
Completion
2028-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04435249 on ClinicalTrials.gov