Mp60-17 off-the-shelf implant to bridge a urethra, multicentre 8-year journey from bench to bed

You have accessJournal of UrologyCME1 Apr 2023MP60-17 OFF-THE-SHELF IMPLANT TO BRIDGE A URETHRA, MULTICENTRE 8-YEAR JOURNEY FROM BENCH TO BED Ganesh Vythilingam, Hans Larsson, Yeoh Wei Sien, Saiful Azli Mohd Zainuddin, Eva-Maria Engelhardt, Anand Sanmugam, Shireen Nah, Sri Hari Singaravel, Yi-Xian Foong, Muhd Khairul Akmal Wak Harto, Kalitha Pinnagoda, Retnagowri Rajandram, Selvalingam Sothilingam, Rajendra C. Thambidorai, Tunku Kamarul Zaman Tunku Zainol Abidin, Jeffrey A. Hubbell, Peter Frey, and Ong Teng Aik Ganesh VythilingamGanesh Vythilingam More articles by this author , Hans LarssonHans Larsson More articles by this author , Yeoh Wei SienYeoh Wei Sien More articles by this author , Saiful Azli Mohd ZainuddinSaiful Azli Mohd Zainuddin More articles by this author , Eva-Maria EngelhardtEva-Maria Engelhardt More articles by this author , Anand SanmugamAnand Sanmugam More articles by this author , Shireen NahShireen Nah More articles by this author , Sri Hari SingaravelSri Hari Singaravel More articles by this author , Yi-Xian FoongYi-Xian Foong More articles by this author , Muhd Khairul Akmal Wak HartoMuhd Khairul Akmal Wak Harto More articles by this author , Kalitha PinnagodaKalitha Pinnagoda More articles by this author , Retnagowri RajandramRetnagowri Rajandram More articles by this author , Selvalingam SothilingamSelvalingam Sothilingam More articles by this author , Rajendra C. ThambidoraiRajendra C. Thambidorai More articles by this author , Tunku Kamarul Zaman Tunku Zainol AbidinTunku Kamarul Zaman Tunku Zainol Abidin More articles by this author , Jeffrey A. HubbellJeffrey A. Hubbell More articles by this author , Peter FreyPeter Frey More articles by this author , and Ong Teng AikOng Teng Aik More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003318.17AboutAbstractPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail Abstract INTRODUCTION AND OBJECTIVE: A surgically efficient and cost-effective tissue engineered implant to reconstruct the urethra has not yet replaced current surgical practice of autologous tissue grafts. Cell based approaches have shown progress. However, these have been associated with high costs and logistical challenges. An acellular, off-the-shelf implant with good regenerative potential is more likely to be used in clinical practice than a cellular implant. METHODS: Collagen implants were developed over a period of 8 years all using bovine collagen as base material. 69 male New Zealand rabbits were utilized to refine the final design. The various implant generations underwent in vitro testing, mechanical analyses, and bench testing by surgeons. The final prototype was implanted in 9 rabbits and 6 dogs. Rabbits were evaluated at 1, 3, and 6 months using visual examination and contrast voiding cysto-urethrography. Biopsies of repaired sites from euthanized rabbits were subjected to histology and immunohistochemistry. The dogs were examined by clinical patency assessment and histology up to 16 months. Approval was given from the Medical Research Ethics Committee at University of Malaya Medical Centre (UMMC),Malaysia, for a 5 patient first in man study to evaluate the implants for substitution urethroplasty of distal urethral strictures of 3cm. The first patients were operated in August 2022 using the acellular collagen implant and the standard surgical technique. RESULTS: Spontaneous urothelial coverage of the implants and smooth muscle cell migration into the implanted area was demonstrated by standard histology and immunohistochemistry in the different time points in the in vivo studies. 2 patients have been implanted with the final prototype bridging urethral defects of less than 3 cm. A peri-ureterogram was done 3 weeks post-surgery and showed no leak and both patients have no voiding complications to date. CONCLUSIONS: The acellular implant may have the potential to be an off the shelf product rendering substitution urethroplasty less harmful. Its mechanical properties allow surgeons to easily recreate a physical conduit while its material properties favour tissue regeneration. A large-scale clinical trial is required to further confirm safety, performance and cost effectiveness. Rabbit urethra: 2cm defect Sacrifice time (months) 1 3 6 Number of animals 1 4 4 Micturition & Patency Normal micturition and patent urethra Dog urethra: 4cm defect Sacrifice time (months) 1 5 and 10 12 and 16 Number of animals 2 2 2 Micturition & Patency Normal micturition and patent urethra Source of Funding: Swiss and Malaysian Grants © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e850 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ganesh Vythilingam More articles by this author Hans Larsson More articles by this author Yeoh Wei Sien More articles by this author Saiful Azli Mohd Zainuddin More articles by this author Eva-Maria Engelhardt More articles by this author Anand Sanmugam More articles by this author Shireen Nah More articles by this author Sri Hari Singaravel More articles by this author Yi-Xian Foong More articles by this author Muhd Khairul Akmal Wak Harto More articles by this author Kalitha Pinnagoda More articles by this author Retnagowri Rajandram More articles by this author Selvalingam Sothilingam More articles by this author Rajendra C. Thambidorai More articles by this author Tunku Kamarul Zaman Tunku Zainol Abidin More articles by this author Jeffrey A. Hubbell More articles by this author Peter Frey More articles by this author Ong Teng Aik More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...