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2. åœå ã§ã¯å€ãã®ãšã¯ãœãœãŒã ãåç²§åãšããŠæµéããŠãããéåœé£åå»è¬åå®å šåŠ(MFDS)ã¯2025幎1æã®åç²§å衚瀺ã»åºåã¬ã€ãã©ã€ã³æ¹å®ã§ããšã¯ãœãœãŒã ãçã®è¡šçŸäœ¿çšãå¶éããŸããããã®ãããå¹æã»æ£äœãæå®ãããããä¿å®çã«ãæ¡å ããããšãååãšããŠããŸãã
3. é©åå¯åŠã»å¹æã®å®æã»æç¶æéã¯èç¶æ ã»å¹Žéœ¢ã»çæŽ»ç¿æ £ã«ãã£ãŠå人差ã倧ãããå šãŠã®æ¹ã«åãçµæãä¿èšŒããããšã¯ã§ããŸãããå ·äœçãªæœè¡å 容ã¯äºåã«ãŠã³ã»ãªã³ã°ã§æ±ºå®ããŸãã
1. ã¯ããœã ãšã¯ïŒå¹¹çްèãšã¯ãœãœãŒã ã®ä»çµã¿
ã¯ããœã (KLOSOME)ã¯å¹¹çްèãšã¯ãœãœãŒã (exosome)ç³»ãšããŠç޹ä»ãããŠããçŽ æã§ãããšã¯ãœãœãŒã ãšã¯çްèãåæ³ããéåžžã«å°ããªå°è(vesicle)ã®ããšã§ãæé·å åã»ãµã€ãã«ã€ã³ã»äžéšã®RNAãªã©ã®æŽ»æ§ç©è³ªãå«ã¿ã现èéã·ã°ãã«äŒéã«é¢ãããšãããŠããŸããã¯ããœã ã¯è£œé äŒç€Ÿã®æ¡å ã«ããã°ã幹现èå¹é€ããã»ã¹ã§åŸããããšã¯ãœãœãŒã ããŒã¹ã®æåãšããŠèª¬æãããŠããŸãã
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| åœå èŠå¶åè | å€ããåç²§åãšããŠæµéïŒéåœé£åå»è¬åå®å šåŠ(MFDS)åºå衚çŸå¶é(2025-01) | éåœé£åå»è¬åå®å šåŠ(MFDS)å»çæ©åšèš±å¯åç® | 補åããšã«éåœé£åå»è¬åå®å šåŠ(MFDS)èš±å¯åé¡ãç°ãªã |
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補åããšã®è©³ããæ¯èŒãæ°ã«ãªãæ¹ã¯ããžã¥ãã«ãã¯ç·åã¬ã€ãããåç §ãã ãããäžã€ã®æœè¡ã«ãã ããå¿ èŠã¯ãªããç°ãªãäœçšãæã€ã±ã¢ãé çªã«çµã¿åãããèšèšãã«ãŠã³ã»ãªã³ã°ã§æ€èšã§ããŸãã
8. Celliqueãã¯ããœã ãéå¶ããæ¹é
Celliqueã¯æ±ååºããµã³ããã®ã¢ã³ããšã€ãžã³ã°ç®èç§ã§ããã¯ããœã ã®ããã«èŠå¶ã»æ ¹æ ãæŽåãããŠããæäžã®é åã§ã¯ã广ãèªåŒµãããæ ¹æ ãšå®å šåºæºãççŽã«èª¬æããã«ãŠã³ã»ãªã³ã°ãçµæã®å®å®æ§ãå·Šå³ãããšèããŠããŸãã
ãã ã»ãŽã代衚é¢é·ã¯äºåã«ãŠã³ã»ãªã³ã°ããæœè¡ã»è¡åŸç¢ºèªãŸã§çŽæ¥æ åœããäœå¶ã§éå¶ããŠããŸããïŒããã¯ã¯ãªããã¯ãæç€ºããŠããéå¶æ¹éã§ãããä¿æè³æ Œã»ç ä¿®æŽã®è©³çްã¯ã«ãŠã³ã»ãªã³ã°æã«ãæ¡å ããŸããïŒå»åž«ãçŽæ¥ã«ãŠã³ã»ãªã³ã°ã»æœè¡ãè¡ããæ ¹æ ã«åºã¥ããŠä»£æ¿æ¡ãäžç·ã«æ¯èŒæ€èšããç¡èã»å®å šç®¡çãããã³ã«ãéµå®ããããšãæåªå ãšããŠããŸãã
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ããããã質å(FAQ)
Q1. ã¯ããœã ã¯ãªããœãŒã ã§ããããšã¯ãœãœãŒã ã§ããïŒ
補é äŒç€Ÿã®å ¬éæ å ±ã«åºã¥ããšãã¯ããœã (KLOSOME®)ã¯å¹¹çްèãšã¯ãœãœãŒã (exosome)ç³»ãšããŠæ¡å ãããŠããŸãããªããœãŒã ïŒäººå·¥è質ééäœïŒãšã¯ç°ãªã系統ã§ãã2ã€ã®èšèã¯äŒŒãŠèãããŸãããåºçºç¹ãç°ãªããããæ¬ã¬ã€ãã¯ãšã¯ãœãœãŒã ã®èгç¹ãã説æããŠããŸããïŒåå¥åç®ã®æ£ç¢ºãªèŠæ Œã¯ã«ãŠã³ã»ãªã³ã°ã§ã確èªãã ãããïŒ
Q2. ã¯ããœã ã¯éåœé£åå»è¬åå®å šåŠ(MFDS)ãèš±å¯ããæ³šå°æœè¡ã§ããïŒ
åœå ã§ã¯å€ãã®ãšã¯ãœãœãŒã ãåç²§åãšããŠæµéããŠãããåç²§åã¯æ¬æ¥æ³šå°çšãšããŠæ¿èªãããå€åœ¢ã§ã¯ãããŸãããéåœé£åå»è¬åå®å šåŠ(MFDS)ã¯2025幎1æã®åç²§å衚瀺ã»åºåã«ãããŠããšã¯ãœãœãŒã ã衚çŸã®äœ¿çšãå¶éããŠããŸãããããã£ãŠãã¯ããœã ããéåœé£åå»è¬åå®å šåŠ(MFDS)ãèš±å¯ããæ³šå°æœè¡ããšæå®ããŠãæ¡å ããããšã¯ããŠãããããèªèº«ã®å Žåã«ã©ã®ãããªæ¹æ³ãé©åãã¯äºåã«ãŠã³ã»ãªã³ã°ã«ãŠæ£ç¢ºã«ãæ¡å ããŸãã
Q3. ãšã¯ãœãœãŒã ã®å¹æã¯ç¢ºããªã®ã§ããïŒ
ãŸã å€§èŠæš¡èšåºã§ç¢ºç«ãããæ®µéã§ã¯ãããŸãããåŠè¡æç®ã§ãšã¯ãœãœãŒã ã»å¹¹çްèåæ³ç©ãç®èååŸ©ã»æççæ¹åã«äœçšããå¯èœæ§ãå ±åãããŠããŸãããå€ãã¯åèšåºã»å°èŠæš¡äºå段éã§ãããé·æå®å šæ§ã»è£œåéã®ã°ãã€ããšãã£ã課é¡ãæ®ã£ãŠãããšèšè¿°ãããŠããŸãããã®ãããå¹æã»æç¶æéãæå®ãããçŸå®çãªæåŸ å€ã§ãæ¡å ããŠããŸãã
Q4. ãšã¯ãœãœãŒã ã¯çŽç²ãªå¹¹çްèãçšããæ²»çãšåãã§ããïŒ
éããŸãããšã¯ãœãœãŒã ã¯çްèãåæ³ããå°ããªå°èäœã§ãããã幹现èãçŽæ¥æ³šå ¥ããæ²»çããšã¯ç°ãªããŸããã¯ããœã ããçŽç²ãªå¹¹çްèãçšããæ²»çããšè¡šçŸããªãçç±ã¯ããã«ãããŸããæ£ç¢ºãªå®çŸ©ãšéçã«ã€ããŠã¯ãã«ãŠã³ã»ãªã³ã°ã§äžç·ã«ã説æããŸãã
Q5. å¯äœçšã泚æäºé ã«ã¯ã©ã®ãããªãã®ããããŸããïŒ
æ³šå ¥ãäŒŽãæœè¡ã®æ§è³ªäžãäžæçãªããã¿ã»èµ€ã¿ã»å åºè¡ãçããããšãããããŸãã«å§çã»çµç¯æãéåžžã«ãŸãã«ææã»ã¢ã¬ã«ã®ãŒåå¿ãå ±åãããããšããããŸããåŠåš ã»æä¹³äžãæŽ»åæ§ææçãæååºè¬ã»å ç«æå¶è¬ã®æçšãèªå·±å ç«çŸæ£ãæåã¢ã¬ã«ã®ãŒãè «çæ¢åŸæŽã®ããæ¹ã¯äºåã«ãŠã³ã»ãªã³ã°ã§å¿ ããç¥ãããã ãããçºçã®æç¡ã»çšåºŠã¯å人差ããããŸãã
Q6. ã¯ããœã ãšãªãžã¥ã©ã³(Rejuran)ã®éãã¯äœã§ããïŒ
äž»èŠæåã®ç³»çµ±ãšèŠå¶äžã®äœçœ®ã¥ããç°ãªããŸããã¯ããœã ã¯å¹¹çްèãšã¯ãœãœãŒã ç³»ïŒå€ããåç²§åãšããŠæµéïŒã§ããããªãžã¥ã©ã³(Rejuran)ã¯PN(ããªãã¯ã¬ãªãã)ç³»ã®éåœé£åå»è¬åå®å šåŠ(MFDS)å»çæ©åšèš±å¯åç®ãšããŠç¥ãããŠããŸããäœçšã»æ ¹æ ã»èŠå¶ãç°ãªããããäœããèªèº«ã®ç®æšã«åããã¯ã«ãŠã³ã»ãªã³ã°ã§æ¯èŒããŠæ±ºå®ããŸãã
Q7. ã«ãŠã³ã»ãªã³ã°ã ãåããããšã¯ã§ããŸããïŒ
ãã¡ããã§ããã¯ããœã ã¯èŠå¶ã»æ ¹æ ãååã«çè§£ããŠããæ±ºå®ããããšãç¹ã«éèŠãªé åã§ãããããã«ãŠã³ã»ãªã³ã°ã§æåŸ å€ãåãããŠããæ±ºå®ãããããšãç¹ã«ãå§ãããŠããŸããæœè¡ã®æç¡ã«é¢ããããã«ãŠã³ã»ãªã³ã°ã®ã¿ããåžæã®æ¹ã¯02-6203-3434ãŸãã¯ã«ã«ãªããŒã¯ã§ãæ°è»œã«ãåãåãããã ãããïŒã«ãŠã³ã»ãªã³ã°ã»æœè¡è²»çšã¯åäººç¶æ ã»èšèšã«ããç°ãªããã«ãŠã³ã»ãªã³ã°ã«ãŠãæ¡å ããŸããïŒ
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CelliniqueïŒæ±åããµã³ããïŒã§ã¯ããã ã»ãŽã代衚é¢é·ãååã«ãŠã³ã»ãªã³ã°ããæœè¡ã»è¡åŸç¢ºèªãŸã§çŽæ¥æ åœããŠããŸããã¯ããœã ã«ãèå³ãããæ¹ã¯ããŸããèªèº«ã®èã®ç¶æ ãšã±ã¢ã®ç®æšãæ°è»œã«ã話ãããã ããã«ãŠã³ã»ãªã³ã°ããå§ããããããšããå§ãããŸããä»ã®ã¹ãã³ããŒã¹ã¿ãŒãšã®æ¯èŒã¯ãžã¥ãã«ãã¯ç·åã¬ã€ãã§ãå ±éã®å®å šåºæºã¯Celliniqueæœè¡å®å šæ¡å ããŒãžã§ã確èªããã ããŸãã
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