Vythilingam, Ganesh and Larsson, Hans M. and Yeoh, Wei Sien and Zainuddin, Saiful Azli Mohd and Engelhardt, Eva-Maria and Sanmugam, Anand and Ch'ng, Yau Lun and Foong, Yi Xian and Harto, Muhd Khairul Akmal Wak and Pinnagoda, Kalitha and Chen, Hui Cheng and Radzi, Rozanaliza and Hiew, Mark and Khairuddin, Nurul Hayah and Rajandram, Retnagowri and Sothilingam, Selvalingam and Rajendrarao, Thambidorai Conjeevaram and Abidin, Tunku Kamarul Zaman Tunku Zainol and Hubbell, Jeffrey A. and Frey, Peter and Joshi, Pankaj M. and Kulkarni, Sanjay B. and Ong, Teng Aik (2025) Off-the-Shelf Implant to Bridge a Urethral Defect: Multicenter 8-Year Journey From Bench to Bed. Urology, 196. pp. 294-299. ISSN 0090-4295, DOI https://doi.org/10.1016/j.urology.2024.12.016.
Full text not available from this repository.Abstract
OBJECTIVE To engineer an acellular mesh to reconstruct the urethra to replace the current surgical practice of using autologous tissue grafts. Cell based approaches have shown progress. However, these have been associated with high costs and logistical challenges. MATERIALS AND METHODS Acellular meshes were engineered using liquid collagen. They underwent in vitro, mechanical and bench testing by surgeons. Sixty-nine male New Zealand rabbits were used to refine the design. The final prototype based on the TissueSpan patented technology was then implanted again in a 2 cm long urethral defect in 9 rabbits and in a 4 cm long defect in 6 dogs. RESULTS The TissueSpan technology platform allows for the manufacturing of tubular and rectangular meshes in different diameters and thicknesses. The tubular mesh acted as physical conduit to gap the urethral defect with a patent urethra demonstrated after 1 month in both animal models. The mesh was absorbed within 1-3 months. Spontaneous urothelial coverage of the mesh and smooth muscle cell migration into the surgical area was demonstrated even in a 4 cm long urethral defect. A first in man clinical trial was subsequently initiated. CONCLUSION The acellular mesh may have the potential to be an off-the-shelf product for substitution urethroplasty. Its mechanical properties allow surgeons to easily create a physical conduit while its material properties favor tissue remodeling. A large-scale clinical trial is still required to further confirm the safety, performance, and patient benefit of this new medical device. UROLOGY 196: 294-299, 2025. (c) 2024 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/ licenses/by-nc-nd/4.0/).
| Item Type: | Article |
|---|---|
| Funders: | UNSPECIFIED |
| Subjects: | R Medicine > R Medicine (General) |
| Divisions: | Faculty of Medicine > Surgery Department Universiti Malaya Medical Centre (UMMC) |
| Depositing User: | Ms. Juhaida Abd Rahim |
| Date Deposited: | 29 Apr 2025 07:20 |
| Last Modified: | 29 Apr 2025 07:20 |
| URI: | http://eprints.um.edu.my/id/eprint/47910 |
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