Composite Biosynthetic Graft for Repair of Long-Segment Tracheal Stenosis: A Pilot In Vivo and In Vitro Feasibility

Teja Karkhanis1, Achu G Byju1, David L Morales2

  • 1From the Department of Biomedical Engineering, Texas A&M University, College Station, Texas.

ASAIO Journal (American Society for Artificial Internal Organs : 1992)
|January 3, 2024
PubMed

Insights

A new biosynthetic graft using porcine small intestinal submucosa extracellular matrix (SIS-ECM) shows promise for repairing long-segment congenital tracheal stenosis (LSCTS) in pediatric patients, improving tracheal tissue regeneration and biomechanical support.

Area of Science:

  • Biomaterials Science
  • Regenerative Medicine
  • Pediatric Surgery

Background:

  • Long-segment congenital tracheal stenosis (LSCTS) in pediatric patients leads to poor surgical outcomes and complications.
  • Current treatments for LSCTS are limited, necessitating novel repair strategies.

Purpose of the Study:

  • To evaluate a novel biosynthetic graft for tracheal repair in pediatric LSCTS.
  • To assess the in vivo efficacy and in vitro biomechanical performance of the graft.

Main Methods:

  • An ovine trachea model was used for in vivo evaluation of the porcine small intestinal submucosa extracellular matrix (SIS-ECM) patch over 8 months.
  • A benchtop lamb trachea model assessed the biomechanical stability of the complete biosynthetic graft (SIS-ECM patch + resorbable polymeric exostent).

Main Results:

  • In vivo: SIS-ECM outperformed bovine pericardium, preventing restenosis and restoring tracheal architecture, vasculature, and epithelial/ciliary structures.
  • In vitro: The biosynthetic graft demonstrated axial and flexural stability, with biomechanical function comparable to native trachea.

Conclusions:

  • The SIS-ECM based biosynthetic graft shows significant potential for tracheal repair in pediatric LSCTS.
  • Further studies are warranted to confirm safety, efficacy, and long-term performance for tracheal defect repair.

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