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Technology Insight: the evolution of tissue-engineered vascular grafts—from research to clinical practice

Abstract

There is a considerable clinical need for alternatives to the autologous vein and artery tissues used for vascular reconstructive surgeries such as CABG, lower limb bypass, arteriovenous shunts and repair of congenital defects to the pulmonary outflow tract. So far, synthetic materials have not matched the efficacy of native tissues, particularly in small diameter applications. The development of cardiovascular tissue engineering introduced the possibility of a living, biological graft that might mimic the functional properties of native vessels. While academic research in the field of tissue engineering in general has been active, as yet there has been no clear example of clinical and commercial success. The recent transition of cell-based therapies from experimental to clinical use has, however, reinvigorated the field of cardiovascular tissue engineering. Here, we discuss the most promising approaches specific to tissue-engineered blood vessels and briefly introduce our recent clinical results. The unique regulatory, reimbursement and production challenges facing personalized medicine are also discussed.

Key Points

  • Tissue-engineered blood vessel technologies should target four criteria to maximize the likelihood of clinical success: appropriate burst pressure (>1,700 mmHg); appropriate fatigue resistance (30 days of in vitro cycling under physiological loading without marked dilation); an autologous endothelium; and reproducible demonstration of these characteristics using human cells

  • The recent transition to clinical use by two tissue-engineering groups suggests that cell-based therapeutics are clinically viable approaches for patients lacking suitable autologous vein/artery for vascular reconstruction

  • To accommodate the increased time and complexity associated with these cell-based solutions, clinicians will have to shift some clinical management decisions from an 'off-the-shelf' reactive strategy toward a more proactive and preventative treatment plan

  • Reimbursement models suggest that the efficacy of these costly therapies will have to approach that of native vein to show a cost–benefit relative to other synthetic grafts

  • Regulatory challenges could hinder large-scale commercialization of autologous cell-based therapies unless lot release and quality criteria are softened from the current regulations, which are more relevant to the larger batch sizes associated with aseptic drug production or cell-based bioprocessing

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Figure 1: The first clinical use of a tissue-engineered blood vessel for high pressure arterial revascularization

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Authors and Affiliations

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Correspondence to Todd McAllister.

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Competing interests

N L'Heureux is Chief Scientific Officer at Cytograft Tissue Engineering, Inc., San Francisco, CA, USA.

N Dusserre is the Senior Vice President of Manufacturing at Cytograft Tissue Engineering, Inc., San Francisco, CA, USA.

T McAllister is Chief Executive Officer at Cytograft Tissue Engineering, Inc., San Francisco, CA, USA.

The other authors declared they have no competing interests.

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L'Heureux et al. (2006) Human tissue-engineered blood vessels for adult arterial revascularization. Nature Medicine 12, 361–365

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L'Heureux, N., Dusserre, N., Marini, A. et al. Technology Insight: the evolution of tissue-engineered vascular grafts—from research to clinical practice. Nat Rev Cardiol 4, 389–395 (2007). https://doi.org/10.1038/ncpcardio0930

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