Abstract 14206: First-in-Human Study of an Autologous In-Body Tissue-Engineered Vascular Graft (Biotube type C) for Hemodialysis Access
Background and Purpose: An arteriovenous (AV) fistula is the current gold standard for chronic hemodialysis access. However, a substantial number of shunt will fail because of stenosis or obstruction at anastomotic site or venous outflow. Tissue-engineered blood vessels have been proposed for dialysis access as an alternative to prosthetic grafts. We developed autologous connective tubular tissues (Biotubes) formed by "in body tissue architecture" technology, based on the tissue encapsulation phenomenon. The technology represents a novel and practical approach to regenerative medicine. Recently, Biotube with designed dimension including wall thickness was developed as type C. This report presents the first-in-human results after a minimum of 3 months of follow-up for the first two patients implanted with Biotube type C.
Methods and Results: Biotube vascular grafts with 5 or 6 mm in diameter and 7 cm in length were prepared as autologous connective tubular tissues with wall thickness of ca. 1mm by embedding of molds, assembled with a silicone center rod and a stainless steel tube, 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, because of repeatable stenosis about every month at venous outflow regions. 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.
Conclusion: This first human study successfully supported the concept of creating dialysis access from autologous connective tissue Biotube grown in patients subcutaneous pouches.
Author Disclosures: Y. Nakayama: None. Y. Kaneko: None. N. Okumura: None.
- © 2016 by American Heart Association, Inc.