Scientific paper:

"A novel hybrid silk-fibroin/polyurethane three-layered vascular graft: towards in situ tissue engineered vascular accesses for haemodialysis.

Keywords:

In situ tissue engineering, haemodialysis vascular access, electrospinning, early cannulation, hybrid vascular graft, fibroin, polyurethane

A novel hybrid silk-fibroin/polyurethane three-layered vascular graft: towards in situ tissue engineered vascular accesses for haemodialysis

Introduction:

Patients undergoing chronic haemodialysis need a vascular access to connect the vascular system to an external dialysis equipment.

However, Clinically available alternatives of vascular access for long-term haemodialysis (currently limited to native arteriovenous fistulae and synthetic grafts) suffer from several drawbacks and are associated to high failure rates. 

The best practice for recurrent long-term haemodialysis is the creation of an AVF, i.e., the direct surgical connection between an artery and a vein, which provides the highest long-term patency rates (approximately 70%) due to its capability of remodelling and evolving together with the patient’s system.

  • Image | courtesy: SVS
    Image | courtesy: SVS
    Image | courtesy: SVS
  • Image | courtesy: University of Cincinnati
    Image | courtesy: University of Cincinnati
    Image | courtesy: University of Cincinnati

However, AVF is not always feasible in all patients (e.g., elderly, diabetics, patients with high Body Mass Index), and it usually requires 6-8 weeks to reach a sufficient maturation stage to allow for puncturing (process known as “arterialization”) 

A novel hybrid silk-fibroin/polyurethane three-layered vascular graft: towards in situ tissue engineered vascular accesses for haemodialysis

Abstract

Clinically available alternatives of vascular access for long-term haemodialysis(currently limited to native arteriovenous fistulae and synthetic grafts) suffer from several drawbacks and are associated to high failure rates. 

Bioprosthetic grafts and tissue-engineered blood vessels are costly alternatives without clearly demonstrated increased performance.  

"In situ tissue engineering could be the ideal approach"

In situ tissue engineering could be the ideal approach to provide a vascularaccess that profits from the advantages of vascular grafts in the short-term (e.g. early cannulation) and of fistulae in the long-term (e.g. high success rates driven by biointegration). 

Hence, in this study a three-layered silk fibroin/polyurethane vascular graft was developed by electrospinning to be applied as long-term haemodialysisvascular access pursuing a 'hybrid' in situ engineering approach (i.e. based on a semi-degradable scaffold).

  • © Bioengineering Laboratories Srl, Cantù, Italy
    © Bioengineering Laboratories Srl, Cantù, Italy
    © Bioengineering Laboratories Srl, Cantù, Italy
  • © Bioengineering Laboratories Srl, Cantù, Italy
    © Bioengineering Laboratories Srl, Cantù, Italy
    © Bioengineering Laboratories Srl, Cantù, Italy
  • © Bioengineering Laboratories Srl, Cantù, Italy
    © Bioengineering Laboratories Srl, Cantù, Italy
    © Bioengineering Laboratories Srl, Cantù, Italy

"three-layered silk fibroin/polyurethane vascular graft"

This Silkothane® graft was characterized concerning morphology, mechanics, physical properties, blood contact and vascular cell adhesion/viability. The full three-layered graft structure, influenced by the polyurethane presence, ensured mechanical properties that are a determinant factor for the success of a vascular access (e.g. vein-graft compliance matching). 

The Silkothane® graft demonstrated early cannulation potential in line with self-sealing commercial synthetic arteriovenous grafts, and a degradability driven by enzymatic activity. 

Moreover, the fibroin-only layers and extracellular matrix-like morphology, presented by the graft, revealed to be crucial in providing a non-haemolytic character, long clotting time, and favourable adhesion of human umbilical vein endothelial cells with increasing viability after 3 and 7 d. 

Accordingly, the proposed approach may represent a step forward towards an in situ engineered hybrid vascular access with potentialities for vein-graft anastomosis stability, early cannulation, and biointegration.

  • "“The collaboration with LifeTec Group, initiated in the context of the Marie Sklodowska-Curie project MUSICARE, has been fertile and fruitful. Their VABIO (vascular bioreactor) platform proved to be an excellent tool to assess the performances of our novel vascular graft, based on the Silkothane® technology, under controlled hemodynamic parameters. The synergy between Bioengineering Laboratories and LifeTec Group will surely continue beyond MUSICARE, allowing both companies to enter and explore the cutting-edge field of semi-degradable substrates for in situ tissue engineering.”"

    Francesco G. Greco
    Chief Executive Officer of Bioengineering Laboratories Srl, Cantù, Italy

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Noemi Vanerio
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Authors:

Sebastião van Uden, Noemi Vanerio, Valentina Catto, Barbara Bonandrini, Matteo Tironi, Marina Figliuzzi, Andrea Remuzzi, Linda Kock, Alberto C L Redaelli, Francesco G Greco, Stefania A. Riboldi 

  • Bioengineering Laboratories S.r.l., Cantù (MB), Italy 
  • Dipartimento di Elettronica Informazione e Bioingegneria, Politecnico di Milano, Milan (MI), Italy 
  • LifeTec Group BV, Eindhoven, The Netherlands 
  • Department of Cardiothoracic Surgery & Amsterdam Cardiovascular Sciences, Amsterdam University Medical Center, Amsterdam, The Netherlands 
  • Department of Chemistry, Materials and Chemical Engineering Giulio Natta, Politecnico di Milano, Milan (MI), Italy 
  • Istituto di Ricerche Farmacologiche Mario Negri IRCCS 
  • Dipartimento di Ingegneria gestionale, dell'informazione e della produzione, Università degli Studi di 

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