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Initial 3-year results of first human use of an in-body tissue-engineered autologous "Biotube" vascular graft for hemodialysis.
J Vasc Access 2019; :1129729819852550JV

Abstract

This study presents the initial 3-year results of the first in-human study of internal shunt restoration using completely autologous vascular grafts, "Biotubes," based on in-body tissue architecture. Biotubes (diameter, 6 mm; length, 7 cm) were prepared as autologous collagenous tubular tissues with approximately 0.5 mm wall thickness by embedding molds (two per patient), assembled with a silicone rod and a stainless steel pipe with many slits, into the patients' abdominal subcutaneous tissue for 2 months. Two female patients with end-stage renal disease were undergoing hemodialysis with a high probability of failure due to repeated stenosis every few months at the venous outflow regions over 1.5 years. Biotubes formed in both patients and were bypassed over the venous stenosis region of the arteriovenous shunt. After bypass with Biotubes without living cells, palpable thrill and typical turbulent flow pattern were observed by pulsed-wave Doppler. Follow-up angiography showed no signs of dilation or stenosis after implantation, and puncture could be performed easily without graft damage. In both cases, stenosis of Biotubes occurred after 3-4 months. In the first case, percutaneous transluminal angioplasty was not required for over 2 years after implantation even after the development of Biotube stenosis. In the second case, stenosis at the proximal anastomotic site of the Biotube became prominent, and percutaneous transluminal angioplasty was needed 7 months after implantation and then repeated at up to 2 years. This was the first human study successfully supporting the concept of internal shunt restoration for hemodialysis using an autologous Biotube.

Authors+Show Affiliations

1 Biotube Co., Ltd., Tokyo, Japan.2 Department of Kidney and Dialysis, Tenri Hospital, Tenri, Japan.2 Department of Kidney and Dialysis, Tenri Hospital, Tenri, Japan.3 Department of Mechanical Systems Engineering, Aichi University of Technology, Gamagori, Japan.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31169047

Citation

Nakayama, Yasuhide, et al. "Initial 3-year Results of First Human Use of an In-body Tissue-engineered Autologous "Biotube" Vascular Graft for Hemodialysis." The Journal of Vascular Access, 2019, p. 1129729819852550.
Nakayama Y, Kaneko Y, Okumura N, et al. Initial 3-year results of first human use of an in-body tissue-engineered autologous "Biotube" vascular graft for hemodialysis. J Vasc Access. 2019.
Nakayama, Y., Kaneko, Y., Okumura, N., & Terazawa, T. (2019). Initial 3-year results of first human use of an in-body tissue-engineered autologous "Biotube" vascular graft for hemodialysis. The Journal of Vascular Access, p. 1129729819852550. doi:10.1177/1129729819852550.
Nakayama Y, et al. Initial 3-year Results of First Human Use of an In-body Tissue-engineered Autologous "Biotube" Vascular Graft for Hemodialysis. J Vasc Access. 2019 Jun 6;1129729819852550. PubMed PMID: 31169047.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Initial 3-year results of first human use of an in-body tissue-engineered autologous "Biotube" vascular graft for hemodialysis. AU - Nakayama,Yasuhide, AU - Kaneko,Yoshiyuki, AU - Okumura,Noriko, AU - Terazawa,Takeshi, Y1 - 2019/06/06/ PY - 2019/6/7/entrez PY - 2019/6/7/pubmed PY - 2019/6/7/medline KW - Biotube KW - bypass KW - hemodialysis KW - in vivo tissue engineering KW - vascular graft SP - 1129729819852550 EP - 1129729819852550 JF - The journal of vascular access JO - J Vasc Access N2 - This study presents the initial 3-year results of the first in-human study of internal shunt restoration using completely autologous vascular grafts, "Biotubes," based on in-body tissue architecture. Biotubes (diameter, 6 mm; length, 7 cm) were prepared as autologous collagenous tubular tissues with approximately 0.5 mm wall thickness by embedding molds (two per patient), assembled with a silicone rod and a stainless steel pipe with many slits, into the patients' abdominal subcutaneous tissue for 2 months. Two female patients with end-stage renal disease were undergoing hemodialysis with a high probability of failure due to repeated stenosis every few months at the venous outflow regions over 1.5 years. Biotubes formed in both patients and were bypassed over the venous stenosis region of the arteriovenous shunt. After bypass with Biotubes without living cells, palpable thrill and typical turbulent flow pattern were observed by pulsed-wave Doppler. Follow-up angiography showed no signs of dilation or stenosis after implantation, and puncture could be performed easily without graft damage. In both cases, stenosis of Biotubes occurred after 3-4 months. In the first case, percutaneous transluminal angioplasty was not required for over 2 years after implantation even after the development of Biotube stenosis. In the second case, stenosis at the proximal anastomotic site of the Biotube became prominent, and percutaneous transluminal angioplasty was needed 7 months after implantation and then repeated at up to 2 years. This was the first human study successfully supporting the concept of internal shunt restoration for hemodialysis using an autologous Biotube. SN - 1724-6032 UR - https://www.unboundmedicine.com/medline/citation/31169047/Initial_3-year_results_of_first_human_use_of_an_in-body_tissue-engineered_autologous_"Biotube"_vascular_graft_for_hemodialysis L2 - http://journals.sagepub.com/doi/full/10.1177/1129729819852550?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -