TEHV

Tissue Engineering Heart Valve (TEHV)

Brief description

Main topic: TEHV, development of engineered tissue and valve prostheses for the heart valve repair and replacement.

Specific objectives:

– To characterize and duplicate human heart valve structure and mechanics;

– To design, prototype and validate innovative valve prostheses with the ability to:

– Induce endogenous tissue growth;

– Increase resistance to calcification;

– Reduce thrombogenicity.

– To develop technologies and strategies for minimally invasive trans-catheter delivery approach.

The method utilized is based on a novel polymer processing technique developed by Dr D’Amore’s group, which is named double component deposition (DCD). DCD allows for the fabrication of fibrous valve prostheses able to induce in-situ tissue growth. The fabrication method has also the ability to control micro/macro structure and mechanical properties of the engineered construct.

Impact:

Nearly 80000 patients/year require a life-saving, valve replacement in the US only. Current clinical practice for valve replacement involves two different classes of devices: mechanical valve prostheses and bio-prostheses. The mechanical valve have good longevity but require chronic anticoagulation therapy, which is in turn associated to a number of risk factors and affects the patients’ quality of life. The second category does not require chronic anticoagulation therapy and yet suffers a number of failure mechanisms with calcific degeneration being one of the most frequent. Technologies developed by Dr D’Amore’ s team aim to overcome the limitations of these two classes of medical devices by introducing engineered heart valves able to re-adjust to somatic growth, resist to calcification and do not require anticoagulants. This research line is functional to develop advanced polymer processing techniques, which can be utilized for different applications. Last, these research efforts are also focusing the prototyping of novel hybrid medical devices based on combined biodegradable metallic and polymeric components. 

Pipeline

  • CLINICAL
    NEED
  • DISEASES
    ANALYSIS
  • DISCOVERY
  • PRECLINICAL
    VALIDATION
  • PRECLINICAL
    DEVELOPMENT
  • CLINICAL
    STUDIES
TEHV: Acute In Vivo Functional Assessment of a Biodegradable Stentless Elastomeric Tricuspid Valve. A) Organ level view of porcine native valve. B) Fiber level view of the native tricuspid valve via scanning electron microscopy. Appearance of ventricular (C) and atrial (D) surface of an elastomeric, biodegradable, stentless tricuspid valve processed with double-component deposition (DCD) electrospinning prepared for the implantation. Hematoxylin and eosin (H&E) staining of poly(carbonate urethane)urea leaflet cross sections prior to implant under low-(E) and high (F)-power magnification demonstrated porous and non-delaminated leaflet architecture. G) In situ view of engineered stentless tricuspid valve. Note how the shape of the engineered valve mimics the configuration observed in the native valve structure in (A). H) Fiber scale structure of the engineered valve via scanning electron microscopy showing comparable fiber intersection density, fiber diameter, and pore size to those observed in (B). After 24 h of implantation, H&E demonstrated that leaflets retained their initial structure with a proteinaceous deposit detected on lower power magnification (I),and no evidence of thrombi and cellular infiltration on higher power examination (J).

Principal Investigator

Contact

adamore@fondazionerimed.com

Therapeutic area:

Products:
Medical devices & tissue engineering

Collaborations:

  • University of Pittsburgh, Pittsburgh, Stati Uniti
  • UPMC, Pittsburgh, Stati Uniti
  • University of Cincinnati, Cincinnati, Stati Uniti
  • IRCCS ISMETT, Palermo, Italia
  • West Virginia University, Morgantown, Stati Uniti
  • Harvard Medical School, Boston, Stati Uniti
  • Universidade Estadual de Campinas, Campinas, Brasile
  • University of Texas at Austin, Austin, Stati Uniti

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Publications

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