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A Study to Assess the Safety, Tolerability and Potential Efficacy of a Tracheal Replacement Consisting of a Tissue-engineered Tracheal Scaffold With Seeded Mesenchymal Cells

NCT02949414 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2018-03-29

No results posted yet for this study

Summary

This is a phase I study to evaluate the safety, efficacy and tolerability of a novel tracheal replacement therapy using cadaveric de-cellularised tracheal scaffold and patients' own mesenchymal cells isolated from a sample of their bone marrow in patients' who suffer from severe tracheal malacia or stenosis.

Conditions

  • Tracheomalacia
  • Tracheal Stenosis

Interventions

PROCEDURE

Cadaveric decellularised tracheal scaffold seeded with autologous mesenchymal cells

The tracheal graft will be manufactured from cadaveric tracheal scaffold and bone marrow derived mesenchymal cells.

Sponsors & Collaborators

  • University College, London

    collaborator OTHER

  • Videregen Limited

    collaborator INDUSTRY

  • Cell Therapy Catapult

    lead OTHER

Principal Investigators

  • Martin Birchall, MD, PhD · University College, London

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2019-09-30
Completion
2024-09-30

Countries

  • United Kingdom

Study Locations

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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 NCT02949414 on ClinicalTrials.gov