Off-the-shelf implant to bridge a urethral defect: multicenter 8-year journey from bench to bed
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 m...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2025
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| Online Access: | http://psasir.upm.edu.my/id/eprint/118735/ http://psasir.upm.edu.my/id/eprint/118735/1/118735.pdf |
| _version_ | 1848867586128740352 |
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| author | Vythilingam, Ganesh Larsson, Hans M. Wei, Sien Yeoh Mohd Zainuddin, Saiful Azli Engelhardt, Eva Maria Sanmugam, Anand Yau, Lun Ch'ng Yi, Xian Foong Wak Harto, Muhd Khairul Akmal Pinnagoda, Kalitha Chen, Hui Cheng Radzi, Rozanaliza Hiew, Mark Khairuddin, Nurul Hayah Rajandram, Retnagowri Sothilingam, Selvalingam Rajendrarao, Thambidorai Conjeevaram Tunku Zainol Abidin, Tunku Kamarul Zaman Hubbell, Jeffrey A. Frey, Peter Joshi, Pankaj M. Kulkarni, Sanjay B. Teng, Aik Ong |
| author_facet | Vythilingam, Ganesh Larsson, Hans M. Wei, Sien Yeoh Mohd Zainuddin, Saiful Azli Engelhardt, Eva Maria Sanmugam, Anand Yau, Lun Ch'ng Yi, Xian Foong Wak Harto, Muhd Khairul Akmal Pinnagoda, Kalitha Chen, Hui Cheng Radzi, Rozanaliza Hiew, Mark Khairuddin, Nurul Hayah Rajandram, Retnagowri Sothilingam, Selvalingam Rajendrarao, Thambidorai Conjeevaram Tunku Zainol Abidin, Tunku Kamarul Zaman Hubbell, Jeffrey A. Frey, Peter Joshi, Pankaj M. Kulkarni, Sanjay B. Teng, Aik Ong |
| author_sort | Vythilingam, Ganesh |
| building | UPM Institutional Repository |
| collection | Online Access |
| description | 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. |
| first_indexed | 2025-11-15T14:38:51Z |
| format | Article |
| id | upm-118735 |
| institution | Universiti Putra Malaysia |
| institution_category | Local University |
| language | English |
| last_indexed | 2025-11-15T14:38:51Z |
| publishDate | 2025 |
| publisher | Elsevier |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | upm-1187352025-07-23T02:15:18Z http://psasir.upm.edu.my/id/eprint/118735/ Off-the-shelf implant to bridge a urethral defect: multicenter 8-year journey from bench to bed Vythilingam, Ganesh Larsson, Hans M. Wei, Sien Yeoh Mohd Zainuddin, Saiful Azli Engelhardt, Eva Maria Sanmugam, Anand Yau, Lun Ch'ng Yi, Xian Foong Wak Harto, Muhd Khairul Akmal Pinnagoda, Kalitha Chen, Hui Cheng Radzi, Rozanaliza Hiew, Mark Khairuddin, Nurul Hayah Rajandram, Retnagowri Sothilingam, Selvalingam Rajendrarao, Thambidorai Conjeevaram Tunku Zainol Abidin, Tunku Kamarul Zaman Hubbell, Jeffrey A. Frey, Peter Joshi, Pankaj M. Kulkarni, Sanjay B. Teng, Aik Ong 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. Elsevier 2025 Article PeerReviewed text en http://psasir.upm.edu.my/id/eprint/118735/1/118735.pdf Vythilingam, Ganesh and Larsson, Hans M. and Wei, Sien Yeoh and Mohd Zainuddin, Saiful Azli and Engelhardt, Eva Maria and Sanmugam, Anand and Yau, Lun Ch'ng and Yi, Xian Foong and Wak Harto, Muhd Khairul Akmal 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 Tunku Zainol Abidin, Tunku Kamarul Zaman and Hubbell, Jeffrey A. and Frey, Peter and Joshi, Pankaj M. and Kulkarni, Sanjay B. and Teng, Aik Ong (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; eISSN: 1527-9995 https://linkinghub.elsevier.com/retrieve/pii/S0090429524011452 10.1016/j.urology.2024.12.016 |
| spellingShingle | Vythilingam, Ganesh Larsson, Hans M. Wei, Sien Yeoh Mohd Zainuddin, Saiful Azli Engelhardt, Eva Maria Sanmugam, Anand Yau, Lun Ch'ng Yi, Xian Foong Wak Harto, Muhd Khairul Akmal Pinnagoda, Kalitha Chen, Hui Cheng Radzi, Rozanaliza Hiew, Mark Khairuddin, Nurul Hayah Rajandram, Retnagowri Sothilingam, Selvalingam Rajendrarao, Thambidorai Conjeevaram Tunku Zainol Abidin, Tunku Kamarul Zaman Hubbell, Jeffrey A. Frey, Peter Joshi, Pankaj M. Kulkarni, Sanjay B. Teng, Aik Ong Off-the-shelf implant to bridge a urethral defect: multicenter 8-year journey from bench to bed |
| title | Off-the-shelf implant to bridge a urethral defect: multicenter 8-year journey from bench to bed |
| title_full | Off-the-shelf implant to bridge a urethral defect: multicenter 8-year journey from bench to bed |
| title_fullStr | Off-the-shelf implant to bridge a urethral defect: multicenter 8-year journey from bench to bed |
| title_full_unstemmed | Off-the-shelf implant to bridge a urethral defect: multicenter 8-year journey from bench to bed |
| title_short | Off-the-shelf implant to bridge a urethral defect: multicenter 8-year journey from bench to bed |
| title_sort | off-the-shelf implant to bridge a urethral defect: multicenter 8-year journey from bench to bed |
| url | http://psasir.upm.edu.my/id/eprint/118735/ http://psasir.upm.edu.my/id/eprint/118735/ http://psasir.upm.edu.my/id/eprint/118735/ http://psasir.upm.edu.my/id/eprint/118735/1/118735.pdf |