Mp06-04 Off-the-Shelf Implant for Urethral Reconstruction: Preliminary Results of a First in Human Study

You have accessJournal of UrologyReconstruction: Urethral Reconstruction (including stricture) I (MP06)1 May 2024MP06-04 OFF-THE-SHELF IMPLANT FOR URETHRAL RECONSTRUCTION: PRELIMINARY RESULTS OF A FIRST IN HUMAN STUDY Ganesh Vythilingam, Hans M. Larsson, Yeoh Wei Sien, Saiful Azli Mohd Zainuddin, Eva-Maria M. Engelhardt, Anand Sanmugam, Yi-Xian Foong, Khairul Harto, Kalitha M. Pinnagoda, Selvalingam Sothilingam, Peter Frey, Pankaj M. Joshi, Sanjay B. Kulkarni, and Ong Teng Aik Ganesh VythilingamGanesh Vythilingam , Hans M. LarssonHans M. Larsson , Yeoh Wei SienYeoh Wei Sien , Saiful Azli Mohd ZainuddinSaiful Azli Mohd Zainuddin , Eva-Maria M. EngelhardtEva-Maria M. Engelhardt , Anand SanmugamAnand Sanmugam , Yi-Xian FoongYi-Xian Foong , Khairul HartoKhairul Harto , Kalitha M. PinnagodaKalitha M. Pinnagoda , Selvalingam SothilingamSelvalingam Sothilingam , Peter FreyPeter Frey , Pankaj M. JoshiPankaj M. Joshi , Sanjay B. KulkarniSanjay B. Kulkarni , and Ong Teng AikOng Teng Aik View All Author Informationhttps://doi.org/10.1097/01.JU.0001009452.79331.fd.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: A multidisciplinary team has worked on the objective to engineer an off-the-shelf implant for urethral reconstruction. This implant is intended to function as a biocompatible substitute for autologous tissue grafts. An off-the-shelf acellular implant offers a logistically appealing approach, consequently enhancing the likelihood of its incorporation as a standard clinical intervention. The patented TissueSpan technology is the final prototype that has now transitioned from a research biomaterial developed in an academic setting to a clinical-grade product produced according to regulatory standards for a first in human study. METHODS: Approval was obtained from the Medical Research Ethics Committee at University of Malaya Medical Centre (UMMC), Malaysia (NMRR-19-1767-48700) for a 5 patient first in human study to evaluate TissueSpan implants for substitution urethroplasty of distal urethral strictures of up to 3cm for a period of 24 months. All subjects had implantations employing standard technique of substitution urethroplasty. Prior to catheter removal a peri-urethrogram was done. Post operatively follow up is done with patients completing an IPSS form and undergoing uroflowmetry at 2, 4, 6, 9, 12, and 24 months. Primary endpoint was to ensure patient safety with implantation and secondary endpoints were clinical performance and benefit. RESULTS: No immediate or delayed rejection was observed locally or systemically in the patients. 2 patients have now completed 1 year post operative period and required urethral dilatation at 10 months. A soft stricture at the proximal anastomosis was seen but overall good graft incorporation. The last 3 patients are 2 months post implantation with no voiding complaints. At the time of conference intermediated report of 6-month data of all patients will be available. CONCLUSIONS: The implant may have the potential to be an off the shelf product for substitution urethroplasty. Preliminary data demonstrates that the implant is safe for human implantation. A large-scale clinical trial is still required to further confirm safety, performance, and patient benefit of the technology. Source of Funding: Regenosca S.A © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e52 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Ganesh Vythilingam More articles by this author Hans M. 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 M. Engelhardt More articles by this author Anand Sanmugam More articles by this author Yi-Xian Foong More articles by this author Khairul Harto More articles by this author Kalitha M. Pinnagoda More articles by this author Selvalingam Sothilingam More articles by this author Peter Frey More articles by this author Pankaj M. Joshi More articles by this author Sanjay B. Kulkarni More articles by this author Ong Teng Aik More articles by this author Expand All Advertisement PDF downloadLoading ...