First Successful Clinical Application of the In Vivo Tissue-Engineered Autologous Vascular Graft

Kato, Naoki; Yamagishi, Masaaki; Kanda, Keiichi; Miyazaki, Tatsuya; Maeda, Yoshinobu; Yamanami, Masashi; Watanabe, Taiji; Yaku, Hitoshi

doi:10.1016/j.athoracsur.2016.06.095

Cited by 24 publications

(21 citation statements)

References 8 publications

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“…The promising progress from clinical trials of in vivo engineered autologous ECM capsules 26 undoubtedly paves the potential avenue toward clinical translation of ECM-C. In light of the encouraging results with rats, we speculate that the demonstrated approach can be readily extended to large animal models.…”

Section: Discussionmentioning

confidence: 92%

In vivo engineered extracellular matrix scaffolds with instructive niches for oriented tissue regeneration

et al. 2019

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Implanted scaffolds with inductive niches can facilitate the recruitment and differentiation of host cells, thereby enhancing endogenous tissue regeneration. Extracellular matrix (ECM) scaffolds derived from cultured cells or natural tissues exhibit superior biocompatibility and trigger favourable immune responses. However, the lack of hierarchical porous structure fails to provide cells with guidance cues for directional migration and spatial organization, and consequently limit the morpho-functional integration for oriented tissues. Here, we engineer ECM scaffolds with parallel microchannels (ECM-C) by subcutaneous implantation of sacrificial templates, followed by template removal and decellularization. The advantages of such ECM-C scaffolds are evidenced by close regulation of in vitro cell activities, and enhanced cell infiltration and vascularization upon in vivo implantation. We demonstrate the versatility and flexibility of these scaffolds by regenerating vascularized and innervated neo-muscle, vascularized neo-nerve and pulsatile neo-artery with functional integration. This strategy has potential to yield inducible biomaterials with applications across tissue engineering and regenerative medicine.

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Section: Discussionmentioning

confidence: 92%

In vivo engineered extracellular matrix scaffolds with instructive niches for oriented tissue regeneration

et al. 2019

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“…Biotubes were confirmed to function as superior autologous small‐diameter vascular prostheses in animal experiments . Finally, biotubes were successfully applied for clinical use for pulmonary arterioplasty of a pediatric patient …”

Section: Introductionmentioning

confidence: 92%

“…3,4 Finally, biotubes were successfully applied for clinical use for pulmonary arterioplasty of a pediatric patient. 5 However, owing to the individual differences in tissue formation, it is sometimes difficult to reliably produce tissues that can withstand use. Particularly for clinical applications in humans, overcoming individual differences is a major problem because the patients (recipients) could be children, elderly people, diabetic patients, and dialysis patients with extremely poor tissue-healing ability.…”

Section: Introductionmentioning

confidence: 99%

Development of xenogeneic decellularized biotubes for off‐the‐shelf applications

et al. 2019

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In earlier studies, we developed in vivo tissue‐engineered, autologous, small‐caliber vascular grafts, called “biotubes,” which withstand systemic blood pressure and exhibit excellent performance as small‐caliber vascular prostheses in animal models. However, biotube preparation takes 4 weeks; therefore, biotubes cannot be applied in emergency situations. Moreover, for responses to various types of surgery, grafts should ideally be readily available in advance. The aim of this study was to develop novel, off‐the‐shelf, small‐caliber vascular grafts by decellularizing in vivo tissue‐engineered xenogeneic tubular materials. Silicone rod molds (diameter: 2 mm, length: 70 mm) placed in subcutaneous pouches of a beagle dog for 4 weeks were harvested with their surrounding connective tissues. Tubular connective tissues were obtained after pulling out the impregnated molds. Subsequently, they were decellularized by perfusion with sodium dodecyl sulfate and Triton X‐100. They were stored as off‐the‐shelf grafts at −20°C for 1 week. The decellularized grafts derived from the beagle dog were xenogeneically transplanted to the abdominal aortas of rats (n = 3). No signs of abnormal inflammation or immunological problems due to the xenogeneic material were observed. Echocardiography confirmed the patency of the grafts at 1 month after implantation. Histological evaluation revealed that the grafts formed neointima on the luminal surface, and that the graft walls had cell infiltration. Little accumulation of CD68‐positive macrophages in the graft wall was observed. Xenogeneic decellularized tubular tissues functioned as small‐caliber vascular grafts, as well as autologous biotubes. This technology enables the easy fabrication of grafts from xenogeneic animals in advance and their storage for at least a week, satisfying the conditions for off‐the‐shelf grafts.

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“…The modified grafts were widely used for many patients; however, adverse events such as rupture occurred in the long-term period. Kato et al 17 used simple silicone rods as a mold to obtain sheet-like iBTA-induced tissues for pediatric pulmonary artery augmentation. However, because wall thickness of the tissues by the classical method was extremely thin, as indicated in our previous study, 6,7 understanding their clinical application was challenging.…”

Section: Discussionmentioning

confidence: 99%

Application of in-body tissue architecture–induced Biotube vascular grafts for vascular access: Proof of concept in a beagle dog model

2019

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Introduction: The first choice of vascular access for hemodialysis is an autogenous arteriovenous fistula, because prosthetic arteriovenous grafts have a high probability of failure. In this study, Biotubes, in-body tissue architecture–induced autologous collagenous tubes, were evaluated for their potential use as vascular access grafts. Three animal implantation models were developed using beagle dogs, and the in vivo performance of Biotubes was observed after implantation in the acute phase as a pilot study. Methods: Biotubes (internal diameter ca. 4.0 mm, length ca. 5.0 cm, and wall thickness ca. 0.7 mm) were prepared through subcutaneous embedding of specially designed molds in beagle dogs for 8 weeks. The Biotubes were then implanted between the common carotid artery and the jugular vein of beagles via three methods, including side-to-side (in) -end-to-end (out) as type 1 (n = 4), side-to-side (both) as type 2 (n = 4), and side-to-end (in) -end-to-side (out) as type 3 (n = 1 using a composite Biotube). Results: Although two cases in type 1 and 2 resulted in Biotube deformation, all cases were patent for 4 weeks and maintained a continuous turbulent flow. At 4 weeks after implantation, percutaneous puncture could be performed repeatedly without aneurysm formation or hemorrhage. Conclusion: Within a short implantation period, with limited animal numbers, this proof-of-concept study showed that Biotubes may have a high potential for use in vascular access.

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First Successful Clinical Application of the In Vivo Tissue-Engineered Autologous Vascular Graft

Abstract: The safety and feasibility of Biotubes for pediatric PA patch augmentation are described. Because Biotubes are completely autologous, they may be ideal material for pediatric PA augmentation.

Cited by 24 publications

References 8 publications

In vivo engineered extracellular matrix scaffolds with instructive niches for oriented tissue regeneration

In vivo engineered extracellular matrix scaffolds with instructive niches for oriented tissue regeneration

Development of xenogeneic decellularized biotubes for off‐the‐shelf applications

Application of in-body tissue architecture–induced Biotube vascular grafts for vascular access: Proof of concept in a beagle dog model

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