Development of Shunt for blood dialysis based on in-body tissue architecture technology

2016 Fiscal Year Final Research Report

• Project/Area Number: 15K15590
• Research Category: Grant-in-Aid for Challenging Exploratory Research
• Allocation Type: Multi-year Fund
• Research Field: Urology
• Research Institution: National Cardiovascular Center Research Institute
• Principal Investigator: Nakayama Yasuhide 国立研究開発法人国立循環器病研究センター, 研究所, 室長 (50250262)
• Project Period (FY): 2015-04-01 – 2017-03-31
• Keywords: 人工血管 / 再生医療 / 透析 / シャント / バスキュラーアクセス

Outline of Final Research Achievements

This study presents the first-in-human results after a minimum of 3 months of follow-up for the first two patients implanted with Biotube. Biotubes were prepared with wall thickness of ca. 1mm by embedding of molds into patients abdominal subcutaneous pouches for 2 months. Two female patients had end-stage renal disease and had been receiving heamodialysis with a high probability of failure. The biotubes after stored for 1 day in a 70% alcohol solution were bypassed by end-to side anastomoses over venous stenosis region of an AV shunt. Palpable thrill and typical turbulent flow pattern by pulsed-wave Doppler were observed. Monthly angiography showed little change in the implanted grafts with no signs of dilation or stenosis with time points up to 3 months. Repeated puncture could be performed without grafts damage. This first human study successfully supported the concept of creating dialysis access from autologous connective tissue Biotube grown in patients subcutaneous pouches.

Free Research Field

再生医療工学、医療機器開発