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發表文獻

2025/07/10

Safety and Tolerability of Intra-Articular Injection of Adipose-Derived Mesenchymal Stem Cells GXCPC1 in 11 Subjects With Knee Osteoarthritis: A Nonrandomized Pilot Study Without a Control Arm (2024)

異體脂肪幹細胞軟實立 GXCPC1® 臨床試驗一期結果顯示,接受治療的膝關節骨關節炎患者中,追蹤 1 年內沒有發生嚴重不良事件 (SAE),顯示其安全性良好。高劑量組 (4 x 10^7 hADSCs) 在疼痛和膝關節功能上有顯著改善,疼痛分數減少幅度介於 −7.773 至 −2.561 分,膝關節功能提升幅度落在 −24.297 至 −10.036 分,顯示 GXCPC1® 在膝關節炎治療上的應用潛力。

Chen, C. F., Chen, Y. C., Fu, Y. S., Tsai, S. W., Wu, P. K., Chen, C. M., Chen, W. M., Wu, H. H., Lee, C. H., Chang, C. L., Lin, P. C., Kao, Y. C., Chen, C. H., & Chuang, M. H. (2024). Safety and Tolerability of Intra-Articular Injection of Adipose-Derived Mesenchymal Stem Cells GXCPC1 in 11 Subjects With Knee Osteoarthritis: A Nonrandomized Pilot Study Without a Control Arm. Cell transplantation33, 9636897231221882.

https://doi.org/10.1177/09636897231221882

The effect of adipose-derived mesenchymal stem cells and chondrocytes with platelet-rich fibrin releasates augmentation by intra-articular injection on acute osteochondral defects in a rabbit model (2018)

在兔子急性骨軟骨缺損模型中,PRFr 與 ADSCs 的聯合注射顯著促進了軟骨再生,修復的軟骨比單獨使用 ADSCs 或 PRFr 更厚、更均勻,顯示組合劑型的療效更優於單獨治療,具備修復骨軟骨缺損的臨床應用潛力。

 Hsu, Y. K., Sheu, S. Y., Wang, C. Y., Chuang, M. H., Chung, P. C., Luo, Y. S., Huang, J. J., Ohashi, F., Akiyoshi, H., & Kuo, T. F. (2018). The effect of adipose-derived mesenchymal stem cells and chondrocytes with platelet-rich fibrin releasates augmentation by intra-articular injection on acute osteochondral defects in a rabbit model. The Knee, 25(6), 1181–1191.

https://doi.org/10.1016/j.knee.2018.10.005

Mesenchymal Stem Cell Secreted-Extracellular Vesicles are Involved in Chondrocyte Production and Reduce Adipogenesis during Stem Cell Differentiation (2022)

本篇研究顯示,國璽提供的人類臍帶和脂肪間質幹細胞 (hWJMSCs & hADSCs) 所產出的外泌體在細胞實驗中表現出軟骨誘導能力,顯著提升 II 型膠原蛋白 (type II collagen) 表現量,此外,其外泌體能顯著減緩脂肪新生。本研究顯示,不同細胞株所產生的外泌體會有一定程度的落差,此外,hADSCs 產出的外泌體具備促進軟骨分化的功效,具高度潛力被應用於未來關節炎治療的臨床應用。

Tsai, Y. C., Cheng, T. S., Liao, H. J., Chuang, M. H., Chen, H. T., Chen, C. H., Zhang, K. L., Chang, C. H., Lin, P. C., & Huang, C. F. (2022). Mesenchymal Stem Cell Secreted-Extracellular Vesicles are Involved in Chondrocyte Production and Reduce Adipogenesis during Stem Cell Differentiation. Tissue engineering and regenerative medicine19(6), 1295–1310.

https://doi.org/10.1007/s13770-022-00490-0

Enhanced Bone Formation in Osteoporotic Mice by a Novel Transplant Combined with Adipose derived Stem Cells and Platelet-rich Fibrin Releasates (2020)

在骨質疏鬆小鼠模型中,與對照組相比 ADSCs 與 PRFr 組合劑型 (ADSCs+PRFr) 顯著提高了骨密度,並表現出更顯著的骨癒合效果。這表明 ADSCs+PRFr 的治療方法在骨質疏鬆應用具臨床潛力,可成為一個新穎的治療策略。

Sheu, S. Y., Hsu, Y. K., Chuang, M. H., Chu, C. M., Lin, P. C., Liao, J. H., Lin, S. Z., & Kuo, T. F. (2020). Enhanced Bone Formation in Osteoporotic Mice by a Novel Transplant Combined with Adipose-derived Stem Cells and Platelet-rich Fibrin Releasates. Cell transplantation29, 963689720927398.

https://doi.org/10.1177/0963689720927398

Regenerative Potential of Platelet-Rich Fibrin Releasate Combined with Adipose Tissue–Derived Stem Cells in a Rat Sciatic Nerve Injury Model (2020)

在大鼠坐骨神經損傷模型中,PRFr 與 ADSCs 的組合劑型與單獨使用 PRFr 或 ADSCs 相比顯著改善神經功能,組合劑型在老鼠行為測試中表現更佳,其修復效果顯著優於未治療對照組。這一結果表明,PRFr 和 ADSCs 的組合劑型相較於單獨治療在神經修復上可產生更好的功效。

Chuang, M. H., Ho, L. H., Kuo, T. F., Sheu, S. Y., Liu, Y. H., Lin, P. C., Tsai, Y. C., Yang, C. H., Chu, C. M., & Lin, S. Z. (2020). Regenerative Potential of Platelet-Rich Fibrin Releasate Combined with Adipose Tissue-Derived Stem Cells in a Rat Sciatic Nerve Injury Model. Cell transplantation29, 963689720919438.

https://doi.org/10.1177/0963689720919438

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