First-in-human exploratory trial assessing safety, feasibility, and efficacy of artificial protein (silk-elastin) in promoting healing in patients with meniscus injuries
Abstract Meniscal tears, especially those in avascular regions, pose a significant risk for osteoarthritis if repair fails. While meniscal repair is the preferred method for preserving knee function, it often has a high failure rate in avascular zones. This study aimed to evaluate the safety and pot...
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Nature Portfolio
2025-02-01
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| Online Access: | https://doi.org/10.1038/s41598-025-88616-x |
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| author | Masakazu Ishikawa Shunya Tsuji Goki Kamei Kyohei Nakata Akinori Nekomoto Naofumi Hashiguchi Tomoyuki Nakasa Atsuo Nakamae Naosuke Kamei Keiichiro Inoue Shingo Kawabata Keiko Ueda Nobuo Adachi |
| author_facet | Masakazu Ishikawa Shunya Tsuji Goki Kamei Kyohei Nakata Akinori Nekomoto Naofumi Hashiguchi Tomoyuki Nakasa Atsuo Nakamae Naosuke Kamei Keiichiro Inoue Shingo Kawabata Keiko Ueda Nobuo Adachi |
| author_sort | Masakazu Ishikawa |
| collection | DOAJ |
| description | Abstract Meniscal tears, especially those in avascular regions, pose a significant risk for osteoarthritis if repair fails. While meniscal repair is the preferred method for preserving knee function, it often has a high failure rate in avascular zones. This study aimed to evaluate the safety and potential efficacy of silk-elastin (SE), an artificial protein with wound-healing properties, for enhancing meniscal repair. Eight patients with meniscal tears in avascular areas underwent arthroscopic repair followed by SE application, including cases of lateral and medial tears, discoid lateral meniscus, and bucket-handle tears. No adverse events or reactions were attributed to SE. At 3 months post-surgery, clinical outcomes and repair sites were evaluated using MRI and arthroscopy. Significant improvements were observed in Lysholm and visual analog scale scores (P < 0.05), with the knee injury and osteoarthritis outcome scores showing significant improvement in the symptom subscale. MRI findings indicated one patient with grade 1 healing, three with grade 2, and four with grade 3 (unhealed). Arthroscopically, six patients demonstrated completely healed menisci, while two showed incomplete healing; none were classified as “unhealed.” These findings suggest that SE is safe and may support meniscal healing in avascular zones, indicating its potential to improve repair outcomes. |
| format | Article |
| id | doaj-art-8c016225ab474b20ae45b6fbb7057441 |
| institution | Kabale University |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj-art-8c016225ab474b20ae45b6fbb70574412025-02-09T12:33:55ZengNature PortfolioScientific Reports2045-23222025-02-0115111310.1038/s41598-025-88616-xFirst-in-human exploratory trial assessing safety, feasibility, and efficacy of artificial protein (silk-elastin) in promoting healing in patients with meniscus injuriesMasakazu Ishikawa0Shunya Tsuji1Goki Kamei2Kyohei Nakata3Akinori Nekomoto4Naofumi Hashiguchi5Tomoyuki Nakasa6Atsuo Nakamae7Naosuke Kamei8Keiichiro Inoue9Shingo Kawabata10Keiko Ueda11Nobuo Adachi12Department of Orthopedic Surgery, Faculty of Medicine, Kagawa UniversityDepartment of Orthopedic Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima UniversityDepartment of Orthopedic Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima UniversityDepartment of Orthopedic Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima UniversityDepartment of Orthopedic Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima UniversityDepartment of Orthopedic Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima UniversityDepartment of Orthopedic Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima UniversityDepartment of Orthopedic Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima UniversityDepartment of Orthopedic Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima UniversitySanyo Chemical IndustriesSanyo Chemical IndustriesTrarnslation Research Center for Medical InnovationDepartment of Orthopedic Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima UniversityAbstract Meniscal tears, especially those in avascular regions, pose a significant risk for osteoarthritis if repair fails. While meniscal repair is the preferred method for preserving knee function, it often has a high failure rate in avascular zones. This study aimed to evaluate the safety and potential efficacy of silk-elastin (SE), an artificial protein with wound-healing properties, for enhancing meniscal repair. Eight patients with meniscal tears in avascular areas underwent arthroscopic repair followed by SE application, including cases of lateral and medial tears, discoid lateral meniscus, and bucket-handle tears. No adverse events or reactions were attributed to SE. At 3 months post-surgery, clinical outcomes and repair sites were evaluated using MRI and arthroscopy. Significant improvements were observed in Lysholm and visual analog scale scores (P < 0.05), with the knee injury and osteoarthritis outcome scores showing significant improvement in the symptom subscale. MRI findings indicated one patient with grade 1 healing, three with grade 2, and four with grade 3 (unhealed). Arthroscopically, six patients demonstrated completely healed menisci, while two showed incomplete healing; none were classified as “unhealed.” These findings suggest that SE is safe and may support meniscal healing in avascular zones, indicating its potential to improve repair outcomes.https://doi.org/10.1038/s41598-025-88616-xMeniscus tearArthroscopic meniscus repairArtificial proteinSilk-elastinNeedle arthroscopeKnee osteoarthritis |
| spellingShingle | Masakazu Ishikawa Shunya Tsuji Goki Kamei Kyohei Nakata Akinori Nekomoto Naofumi Hashiguchi Tomoyuki Nakasa Atsuo Nakamae Naosuke Kamei Keiichiro Inoue Shingo Kawabata Keiko Ueda Nobuo Adachi First-in-human exploratory trial assessing safety, feasibility, and efficacy of artificial protein (silk-elastin) in promoting healing in patients with meniscus injuries Scientific Reports Meniscus tear Arthroscopic meniscus repair Artificial protein Silk-elastin Needle arthroscope Knee osteoarthritis |
| title | First-in-human exploratory trial assessing safety, feasibility, and efficacy of artificial protein (silk-elastin) in promoting healing in patients with meniscus injuries |
| title_full | First-in-human exploratory trial assessing safety, feasibility, and efficacy of artificial protein (silk-elastin) in promoting healing in patients with meniscus injuries |
| title_fullStr | First-in-human exploratory trial assessing safety, feasibility, and efficacy of artificial protein (silk-elastin) in promoting healing in patients with meniscus injuries |
| title_full_unstemmed | First-in-human exploratory trial assessing safety, feasibility, and efficacy of artificial protein (silk-elastin) in promoting healing in patients with meniscus injuries |
| title_short | First-in-human exploratory trial assessing safety, feasibility, and efficacy of artificial protein (silk-elastin) in promoting healing in patients with meniscus injuries |
| title_sort | first in human exploratory trial assessing safety feasibility and efficacy of artificial protein silk elastin in promoting healing in patients with meniscus injuries |
| topic | Meniscus tear Arthroscopic meniscus repair Artificial protein Silk-elastin Needle arthroscope Knee osteoarthritis |
| url | https://doi.org/10.1038/s41598-025-88616-x |
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