訊息與活動幹細胞新資訊
  • 【衛福部資訊】細胞治療大解密

    <p><span style="font-size:20px;"><span style="font-family:微軟正黑體;">衛生福利部於2019年7月4日公布經核准之細胞治療醫院及治療項目,衛福部表示,依據特定醫療技術檢查檢驗醫療儀器施行或使用管理辦法(簡稱特管辦法)規定,醫療機構應擬定細胞治療施行計畫,須經衛福部核准,並向地方政府衛生局登記後,始得施行。</span></span></p> <p><span style="font-size:20px;"><span style="font-family:微軟正黑體;">關於細胞治療的相關資訊,皆可透過衛福部網站查詢。</span></span><br /> &nbsp;</p> <p><a href="https://celltherapy.mohw.gov.tw/index.htm"><span style="font-size:20px;"><span style="font-family:微軟正黑體;">衛生福利部 細胞治療技術資訊專區</span></span></a><br /> &nbsp;</p> <p>&nbsp;</p>

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  • 你知道「幹細胞」對人體有多重要?

    <p style="margin-bottom:6.0pt; text-align:justify">《 此文章刊登於 台兒月刊 - 4月號 》</p> <p><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span style="background:white">台灣衛生福利部</span><span lang="EN-US" style="background:white">2018</span><span style="background:white">年</span><span lang="EN-US" style="background:white">9</span><span style="background:white">月發布「特定醫療技術檢查檢驗醫療儀器施行或使用管理辦法」修正條文,開放</span><span lang="EN-US" style="background:white">6</span><span style="background:white">項自體細胞治療技術</span><span style="background:white">,包含自體免疫細胞用於</span><span style="background:white">標準治療無效的癌症病人與實體癌末期病人,</span><span style="background:white">以及體細胞(包含幹細胞)應用於組織損傷後的再生治療。</span> </span></span></p> <p><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span style="background:white"><span style="letter-spacing:.7pt">所謂細胞治療係指使用取自同種自體(</span></span><span lang="EN-US" style="background:white"><span style="letter-spacing:.7pt">autologous</span></span><span style="background:white"><span style="letter-spacing:.7pt">)、同種異體(</span></span><span lang="EN-US" style="background:white"><span style="letter-spacing:.7pt">allogeneic</span></span><span style="background:white"><span style="letter-spacing:.7pt">),或異種異體(</span></span><span lang="EN-US" style="background:white"><span style="letter-spacing:.7pt">xenogeneic</span></span><span style="background:white"><span style="letter-spacing:.7pt">)並經體外培養後的細胞,以達到疾病治療或預防目的之醫療技術。</span></span></span></span></p> <p style="margin-bottom:6.0pt; text-align:justify"><br /> <span style="color:#8e44ad;"><strong><span style="font-family:微軟正黑體;"><span style="font-size:20px;"><span lang="EN-US">CAR-T</span>免疫細胞治療</span></span></strong></span></p> <p style="margin-bottom:6.0pt; text-align:justify"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span style="background:white">嵌合抗原受體</span><span lang="EN-US" style="background:white">T</span><span style="background:white">細胞(</span><span lang="EN-US" style="background:white">Chimeric antigen receptor T cells</span><span style="background:white">,</span><span lang="EN-US">CAR-T</span>)是免疫細胞治療的一種,<span lang="EN-US">CAR-T</span>是取得癌症患者的<span lang="EN-US">T</span>細胞,用人工方式進行基因修飾,使得<span lang="EN-US">T</span>細胞具有更好的辨識和毒殺癌細胞能力。人工基因修飾後的<span lang="EN-US">T</span>細胞於生產廠內大量擴增培養,然後重新輸入患者體內進行治療。<span lang="EN-US" style="background:white">2017</span><span style="background:white">年</span><span lang="EN-US" style="background:white">8</span><span style="background:white">月,諾華的</span><span lang="EN-US" style="background:white">CAR-T</span><span style="background:white">治療白血病產品</span><span lang="EN-US" style="background:white">Kymriah</span><span style="background:white">由美國</span><span lang="EN-US" style="background:white">FDA</span><span style="background:white">首次批准上市,但要價不斐,</span><span style="background:white">定價為</span><span lang="EN-US" style="background:white">475,000</span><span style="background:white">美元。</span></span></span></p> <p style="text-align:justify"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span lang="EN-US">CAR-T</span>治療可能引發一系列副作用,特別嚴重的併發症是細胞因子釋放綜合症(<span lang="EN-US">Cytokine release syndrome, CRS</span>),此症狀可能會產生危險的高熱、極度疲勞、呼吸困難、血壓急劇下降。<span lang="EN-US">Dana-Farber</span>研究所細胞治療計劃臨床總監<span lang="EN-US">Caron Jacobson</span>博士指出,<span lang="EN-US">CRS</span>之後經常會發生第二波副作用,這些問題可能包括震顫、頭痛、混亂、失去平衡、說話困難、癲癇,以及幻覺產生。這些症狀的原因尚不清楚,通常持續數天至數周。</span></span></p> <p style="text-align:justify"><br /> <span style="color:#8e44ad;"><strong><span style="font-size:20px;"><span style="font-family:微軟正黑體;">神經幹細胞治療</span></span></strong></span></p> <p style="text-align:justify"><span style="font-size:14px;"><span style="font-family:微軟正黑體;">一般認為使用神經幹細胞治療神經相關疾病是直接而有效的,但神經幹細胞來源取得困難,體外培養技術難度高,故產業開發進度緩慢。</span></span></p> <table class="MsoTableGrid" style="width:429.75pt; border-collapse:collapse; border:solid windowtext 1.0pt" width="0"> <tbody> <tr> <td style="width:110.8pt; border:solid windowtext 1.0pt; background:#deeaf6" width="148"> <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;">公司</span></span></p> </td> <td style="width:99.2pt; border:solid windowtext 1.0pt; border-left:none; background:#deeaf6" width="132"> <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;">細胞</span></span></p> </td> <td style="width:2.0cm; border:solid windowtext 1.0pt; border-left:none; background:#deeaf6" width="76"> <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;">產品</span></span></p> </td> <td style="width:4.0cm; border:solid windowtext 1.0pt; border-left:none; background:#deeaf6" width="151"> <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;">適應症</span></span></p> </td> <td style="width:49.65pt; border:solid windowtext 1.0pt; border-left:none; background:#deeaf6" width="66"> <p align="center" style="text-align:center; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;">進度</span></span></p> </td> </tr> <tr> <td style="width:110.8pt; border:solid windowtext 1.0pt; border-top:none" width="148"> <p style="padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span lang="EN-US">ReNeuron Limited</span></span></span></p> </td> <td style="width:99.2pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="132"> <p style="padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;">人胎來源神經幹細胞</span></span></p> </td> <td style="width:2.0cm; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="76"> <p style="padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span lang="EN-US">CTX0E03</span></span></span></p> </td> <td style="width:4.0cm; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="151"> <p style="padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;">中風失能</span></span></p> </td> <td style="width:49.65pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="66"> <p style="padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span lang="EN-US">Phase II</span></span></span></p> </td> </tr> <tr> <td rowspan="3" style="width:110.8pt; border:solid windowtext 1.0pt; border-top:none" width="148"> <p style="padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span lang="EN-US">Seneca biopharmaceuticals, Inc.</span></span></span></p> </td> <td rowspan="3" style="width:99.2pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="132"> <p style="padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;">人胎來源神經幹細胞</span></span></p> </td> <td rowspan="3" style="width:2.0cm; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="76"> <p style="padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span lang="EN-US">NSI-566</span></span></span></p> </td> <td style="width:4.0cm; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="151"> <p style="padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span style="background:white">肌萎縮性脊髓側索硬化症</span></span></span></p> </td> <td style="width:49.65pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="66"> <p style="padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span lang="EN-US">Phase II</span></span></span></p> </td> </tr> <tr> <td style="width:4.0cm; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="151"> <p style="padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span style="background:white">缺血性腦中風</span></span></span></p> </td> <td style="width:49.65pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="66"> <p style="padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span lang="EN-US">Phase II</span></span></span></p> </td> </tr> <tr> <td style="width:4.0cm; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="151"> <p style="padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span style="background:white">脊髓損傷</span></span></span></p> </td> <td style="width:49.65pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="66"> <p style="padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span lang="EN-US">Phase I</span></span></span></p> </td> </tr> <tr> <td style="width:110.8pt; border:solid windowtext 1.0pt; border-top:none" width="148"> <p style="padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span lang="EN-US">International Stem Cell Corporation</span></span></span></p> </td> <td style="width:99.2pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="132"> <p style="padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;">孤雌生殖來源神經幹細胞<span lang="EN-US"> (</span>註<span lang="EN-US">)</span></span></span></p> </td> <td style="width:2.0cm; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="76"> <p style="padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span lang="EN-US">ISC-hpNSC</span></span></span></p> </td> <td style="width:4.0cm; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="151"> <p style="padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;">帕金森氏症</span></span></p> </td> <td style="width:49.65pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="66"> <p style="padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span lang="EN-US">Phase I/IIa</span></span></span></p> </td> </tr> </tbody> </table> <p style="text-align:justify"><strong><u>神經幹細胞產品開發一覽表</u></strong><br /> <span style="font-size:12px;"><span style="font-family:微軟正黑體;">資料來源:宣捷細胞生物製藥股份有限公司整理<br /> 註:未完成第二次減數分裂、仍帶有雙套染色體的卵細胞,施予化學及電刺激,促使其進行分裂形成囊胚。</span></span></p> <p style="text-align:justify"><br /> <span style="color:#8e44ad;"><strong><span style="font-size:20px;"><span style="font-family:微軟正黑體;">間質幹細胞治療</span></span></strong></span></p> <p style="margin-bottom:6.0pt; text-align:justify"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span style="line-height:20.0pt">間質幹細胞來源取得無倫理問題,可以異體使用不會有排斥問題,已成為幹細胞研究的最重要課題。其中臍帶相較於其他來源,能夠取得更大量、更年輕的間質幹細胞,這已成為繼骨髓、周邊血和臍帶血來源後,理想的產業化細胞來源<span style="background:white">。</span></span></span></span><br /> <span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span style="background:white"><span style="line-height:20.0pt"><span style="background:white"><span style="font-weight:normal">不同組織來源的間質幹細胞均能符合國際細胞治療協會(</span></span><span lang="EN-US"><span style="font-weight:normal">International Society for Cell &amp; Gene Therapy</span></span><span style="font-weight:normal">,</span><span lang="EN-US"><span style="background:white"><span style="font-weight:normal">ISCT</span></span></span><span style="background:white"><span style="font-weight:normal">)制定的最低標準,即:</span></span><span lang="EN-US"><span style="background:white"><span style="font-weight:normal">(1)</span></span></span><span style="background:white"><span style="font-weight:normal">貼附型生長;</span></span><span lang="EN-US"><span style="background:white"><span style="font-weight:normal">(2)</span></span></span><span style="background:white"><span style="font-weight:normal">表現特殊細胞表面抗原</span></span><span lang="EN-US"><span style="background:white"><span style="font-weight:normal">CD73</span></span></span><span style="background:white"><span style="font-weight:normal">、</span></span><span lang="EN-US"><span style="background:white"><span style="font-weight:normal">CD90</span></span></span><span style="background:white"><span style="font-weight:normal">、</span></span><span lang="EN-US"><span style="background:white"><span style="font-weight:normal">CD105</span></span></span><span style="background:white"><span style="font-weight:normal">,不表達</span></span><span lang="EN-US"><span style="background:white"><span style="font-weight:normal">CD45</span></span></span><span style="background:white"><span style="font-weight:normal">、</span></span><span lang="EN-US"><span style="background:white"><span style="font-weight:normal">CD34</span></span></span><span style="background:white"><span style="font-weight:normal">、</span></span><span lang="EN-US"><span style="background:white"><span style="font-weight:normal">HLA-DR</span></span></span><span style="background:white"><span style="font-weight:normal">、</span></span><span lang="EN-US"><span style="background:white"><span style="font-weight:normal">CD14</span></span></span><span style="background:white"><span style="font-weight:normal">或</span></span><span lang="EN-US"><span style="background:white"><span style="font-weight:normal">CD11b</span></span></span><span style="background:white"><span style="font-weight:normal">、</span></span><span lang="EN-US"><span style="background:white"><span style="font-weight:normal">CD79alpha</span></span></span><span style="background:white"><span style="font-weight:normal">或</span></span><span lang="EN-US"><span style="background:white"><span style="font-weight:normal">CD19</span></span></span><span style="background:white"><span style="font-weight:normal">;</span></span><span lang="EN-US"><span style="background:white"><span style="font-weight:normal">(3)</span></span></span><span style="background:white"><span style="font-weight:normal">能在體外分化成為硬骨細胞(</span></span><span lang="EN-US"><span style="background:white"><span style="font-weight:normal">Osteocytes</span></span></span><span style="background:white"><span style="font-weight:normal">)、脂肪細胞(</span></span><span lang="EN-US"><span style="background:white"><span style="font-weight:normal">Adipocytes</span></span></span><span style="background:white"><span style="font-weight:normal">)及軟骨細胞(</span></span><span lang="EN-US"><span style="background:white"><span style="font-weight:normal">Chondrocytes</span></span></span><span style="background:white"><span style="font-weight:normal">)。</span></span></span></span></span></span></p> <table class="MsoTableGrid" style="border-collapse:collapse; border:solid windowtext 1.0pt"> <tbody> <tr> <td style="width:104.65pt; border:solid windowtext 1.0pt" width="140"> <h1 style="margin:0cm; margin-bottom:.0001pt; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span style="line-height:20.0pt"><span style="background:white"><span style="font-weight:normal">表達</span></span></span></span></span></h1> </td> <td style="width:313.45pt; border:solid windowtext 1.0pt; border-left:none" width="418"> <h1 style="margin:0cm; margin-bottom:.0001pt; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span style="line-height:20.0pt"><span lang="EN-US"><span style="background:white"><span style="font-weight:normal">CD73</span></span></span><span style="background:white"><span style="font-weight:normal">、</span></span><span lang="EN-US"><span style="background:white"><span style="font-weight:normal">CD90</span></span></span><span style="background:white"><span style="font-weight:normal">、</span></span><span lang="EN-US"><span style="background:white"><span style="font-weight:normal">CD105</span></span></span></span></span></span></h1> </td> </tr> <tr> <td style="width:104.65pt; border:solid windowtext 1.0pt; border-top:none" width="140"> <h1 style="margin:0cm; margin-bottom:.0001pt; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span style="line-height:20.0pt"><span style="background:white"><span style="font-weight:normal">不表達</span></span></span></span></span></h1> </td> <td style="width:313.45pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt" width="418"> <h1 style="margin:0cm; margin-bottom:.0001pt; padding:0cm 5.4pt 0cm 5.4pt"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span style="line-height:20.0pt"><span lang="EN-US"><span style="background:white"><span style="font-weight:normal">CD45</span></span></span><span style="background:white"><span style="font-weight:normal">、</span></span><span lang="EN-US"><span style="background:white"><span style="font-weight:normal">CD34</span></span></span><span style="background:white"><span style="font-weight:normal">、</span></span><span lang="EN-US"><span style="background:white"><span style="font-weight:normal">HLA-DR</span></span></span><span style="background:white"><span style="font-weight:normal">、</span></span><span lang="EN-US"><span style="background:white"><span style="font-weight:normal">CD14</span></span></span><span style="background:white"><span style="font-weight:normal">或</span></span><span lang="EN-US"><span style="background:white"><span style="font-weight:normal">CD11b</span></span></span><span style="background:white"><span style="font-weight:normal">、</span></span><span lang="EN-US"><span style="background:white"><span style="font-weight:normal">CD79alpha</span></span></span><span style="background:white"><span style="font-weight:normal">或</span></span><span lang="EN-US"><span style="background:white"><span style="font-weight:normal">CD19</span></span></span></span></span></span></h1> </td> </tr> </tbody> </table> <p style="text-align:justify"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><u><strong><span lang="EN-US"><span style="background:white">MSC</span></span></strong></u><span style="background:white"><u><strong>表面抗原</strong></u></span></span></span><br /> <span style="font-size:12px;"><span style="font-family: 微軟正黑體;">資料來源:宣捷細胞生物製藥股份有限公司</span></span></p> <h1 style="margin:0cm; margin-bottom:.0001pt; text-align:justify"><br /> <span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span style="background:white"><span style="line-height:20.0pt"><span style="background:white"><span style="font-weight:normal">但仍有不少研究顯示不同組織來源的間質幹細胞具有某些差異性,因此</span></span><strong><span style="background:white"><span style="font-weight:normal">開發的合適的產業化生產技術是獲得相對安全、高品質</span></span></strong><span style="background:white"><span style="font-weight:normal">間質幹細胞</span></span><strong><span style="background:white"><span style="font-weight:normal">的關鍵。</span></span></strong></span></span></span></span></h1> <p style="text-align:justify"><img alt="" src="/official-web/ckupload/001.jpg" /><br /> <span style="font-size:14px;"><span style="font-family:微軟正黑體;"><u><strong>臍帶間質幹細胞的產業化生產</strong></u></span></span><br /> <span style="font-size:12px;"><span style="font-family:微軟正黑體;">資料來源:宣捷細胞生物製藥股份有限公司</span></span></p> <p class="CxSpFirst" style="text-align:justify"><br /> <span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span style="line-height:20.0pt">間質幹細胞治療<span style="background:white">的作用機轉仍未完全了解,關於</span>間質幹細胞<span style="background:white">治療的體外(</span><span lang="EN-US" style="background:white">in vitro</span><span style="background:white">)和體內(</span><span lang="EN-US" style="background:white">in vivo</span><span style="background:white">)證據可能涉及多種途徑,包含觸發多種細胞因子旁分泌效果(</span><span lang="EN-US" style="background:white">Paracrine effect</span><span style="background:white">)、促進血管新生、促進內源性幹細胞生長及分化、抑制纖維化、抑制細胞死亡、抑制多種免疫細胞活化以及抗發炎反應等。</span></span></span></span></p> <p style="text-align:justify"><img alt="" src="/official-web/ckupload/002.jpg" /><br /> <span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span style="background:white"><u><strong>幹細胞治療機轉</strong></u></span></span></span><br /> <span style="font-size:12px;"><span style="font-family:微軟正黑體;"><span style="background:white">資料來源:<span lang="EN-US">Fernando et al., 2012. <span style="background-image:initial"><span style="background-position:initial"><span style="background-size:initial"><span style="background-repeat:initial"><span style="background-attachment:initial"><span style="background-origin:initial"><span style="background-clip:initial">Biological Research</span></span></span></span></span></span></span></span></span></span></span></p> <p style="text-align:justify"><br /> <span style="font-size:14px;"><span style="font-family:微軟正黑體;">細胞治療在技術與法規成熟下,歷年經過各國衛生監管單位許可上市的產品日益增加。<span style="background:white">倘若能利用這些細胞,針對難治性疾病著手,開發為成熟的治療產品,進而改善生活品質,那真是藥物史上一大進步。</span></span></span></p> <p style="text-align:justify"><br /> <span style="color:#8e44ad;"><strong><span style="font-size:20px;"><span style="font-family:微軟正黑體;"><span style="line-height:20.0pt">儲存間質幹細胞的必要性</span></span></span></strong></span></p> <p class="CxSpMiddle" style="text-align:justify"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span style="line-height:20.0pt">目前幹細胞治療的研究中,間質幹細胞可有效幫助的疾病包括帕金森氏症、阿茲海默症、脊椎創傷、肝硬化等疾病。</span></span></span></p> <p class="CxSpMiddle" style="text-align:justify"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span style="line-height:20.0pt"><img alt="yes" height="23" src="https://www.meribank.com.tw:18443/official-manage/assets/ckeditor/plugins/smiley/images/thumbs_up.png" title="yes" width="23" />分化能力強<br /> 間質幹細胞培養速度快,可分化成人體內多數器官組織及細胞。</span></span></span></p> <p class="CxSpMiddle" style="text-align:justify"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span style="line-height:20.0pt"><img alt="yes" height="23" src="https://www.meribank.com.tw:18443/official-manage/assets/ckeditor/plugins/smiley/images/thumbs_up.png" title="yes" width="23" />無須配對<br /> 間質幹細胞的抗原性比其他幹細胞小,不易引起移植物抗宿主病<span lang="EN-US">(GvHD)</span>,寶寶及家人均可使用。</span></span></span></p> <p class="CxSpMiddle" style="text-align:justify"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span style="line-height:20.0pt"><img alt="yes" height="23" src="https://www.meribank.com.tw:18443/official-manage/assets/ckeditor/plugins/smiley/images/thumbs_up.png" title="yes" width="23" />免疫調節作用<br /> 研究表明,幹細胞的在人體內的免疫調節能力可有效的降低異常免疫反應。</span></span></span></p> <p class="CxSpMiddle" style="text-align:justify"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span style="line-height:20.0pt"><img alt="yes" height="23" src="https://www.meribank.com.tw:18443/official-manage/assets/ckeditor/plugins/smiley/images/thumbs_up.png" title="yes" width="23" />未來醫學應用<br /> 運用間質幹細胞體外增生與分化能力,在未來醫學應用上,如組織工程、再生醫學、細胞療法等領域,成為技術發展的重要關鍵。</span></span></span></p> <p class="CxSpMiddle" style="text-align:justify"><br /> <span style="color:#8e44ad;"><strong><span style="font-size:20px;"><span style="font-family: 微軟正黑體;">儲存臍帶血的必要性</span></span></strong></span></p> <p class="CxSpMiddle" style="text-align:justify"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span style="line-height:20.0pt">「臍帶血」是指嬰兒出生時,存在於臍帶及胎盤內的血液,含有豐富的造血幹細胞。每個嬰兒能夠取得的臍帶血量不同,通常為<span lang="EN-US">50c.c.</span>到<span lang="EN-US">100c.c.</span>,可供<span lang="EN-US">30</span>公斤以下的小朋友使用。</span></span></span></p> <p class="CxSpMiddle" style="text-align:justify"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span style="line-height:20.0pt">目前臍帶血移植已逐漸取代骨髓移植,用來治療血液、免疫及新陳代謝方面等疾病。因臍帶血具有以下特性:</span></span></span></p> <p class="CxSpMiddle" style="text-align:justify"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span style="line-height:20.0pt"><img alt="yes" height="23" src="https://www.meribank.com.tw:18443/official-manage/assets/ckeditor/plugins/smiley/images/thumbs_up.png" title="yes" width="23" />配對較骨髓移植容易</span></span></span><br /> <span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span style="line-height:20.0pt">造血幹細胞移植前,需進行人類白血球抗原<span lang="EN-US">(HLA Typing)</span>配對,降低免疫排斥作用的風險。臍帶血是較原始未分化完全的造血幹細胞,因此配對相容之要求比成人的骨髓、周邊血幹細胞來得低。</span></span></span></p> <p class="CxSpMiddle" style="text-align:justify"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span style="line-height:20.0pt"><img alt="yes" height="23" src="https://www.meribank.com.tw:18443/official-manage/assets/ckeditor/plugins/smiley/images/thumbs_up.png" title="yes" width="23" />解凍後立即使用</span></span></span><br /> <span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span style="line-height:20.0pt">臍帶血自體保存並自體移植者,不會產生排斥反應。不需等待他人配對及捐贈,臍帶血解凍後即可使用,把握黃金治療時間。</span></span></span></p> <p class="CxSpMiddle" style="text-align:justify"><span style="font-size:14px;"><span style="font-family:微軟正黑體;"><span style="line-height:20.0pt"><img alt="yes" height="23" src="https://www.meribank.com.tw:18443/official-manage/assets/ckeditor/plugins/smiley/images/thumbs_up.png" title="yes" width="23" />品質比骨髓幹細胞好</span></span></span><br /> <span style="font-size:14px;"><span style="font-family:微軟正黑體;">臍帶血是較原始未分化完全的造血幹細胞,分化能力較骨髓活躍,且臍帶血較少受到環境、病毒、藥物等汙染,細胞品質比骨髓更為純淨。</span></span></p> <p style="text-align:justify">&nbsp;</p>

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    <p><span style="font-size:14px;"><span style="font-family:微軟正黑體;">資料來源:衛生福利部</span></span></p> <p><span style="font-size:14px;"><span style="font-family:微軟正黑體;">衛生福利部發布「特定醫療技術檢查檢驗醫療儀器施行或使用管理辦法」修正條文(以下稱特管辦法),開放6項細胞治療技術,適用對象包括自體免疫細胞治療,用於標準治療無效的癌症病人與實體癌末期病人;自體軟骨細胞移植用於膝關節軟骨缺損;自體脂肪幹細胞移植用於大面積燒傷及困難癒合傷口等。同時,衛福部刻正推動「再生醫療製劑管理條例(草案)」立法,未來可縮短再生醫療製劑上市的期程並加強安全監控。雙法共同建構我國再生醫療管理制度,促進生物製藥產業之發展。</span></span></p> <p><span style="font-size:14px;"><span style="font-family:微軟正黑體;">衛福部表示,依現行規定,細胞治療須依醫療法規定進行人體試驗,為使細胞治療技術可早日應用於有需要之國人,爰修正特管辦法,將國外已施行、風險性低,或已經於國內實施人體試驗累積達一定個案數,安全性可確定、成效可預期之細胞治療項目(如附件),開放使用於符合適應症之臨床治療個案,並訂定相關規定,以確保施行品質、保障病患權益,該辦法重點如下:</span></span></p> <ul> <li><span style="font-size:14px;"><span style="font-family:微軟正黑體;">醫療機構施行細胞治療技術前,應擬定計畫,經中央主管機關核准;細胞治療計畫應載明機構名稱、施行醫師、治療項目與適應症、治療方式、費用及收費方式、效果追蹤、同意書範本與不良反應救濟措施等。</span></span></li> <li><span style="font-size:14px;"><span style="font-family:微軟正黑體;">為確保病人權益與施行品質,施行細胞治療之醫療機構,每年需向中央主管機關提出年度施行結果報告,若有不良事件發生數或嚴重度明顯異常者,終止其施行。各醫療機構之實施計畫及年度施行結果報告摘要與相關資訊,亦將於本部網頁公開供民眾查詢。</span></span></li> <li><span style="font-size:14px;"><span style="font-family:微軟正黑體;">細胞治療過程涉及細胞處理、培養或儲存者,應備有或委託符合人體細胞組織優良操作(GTP)相關規範之細胞製備場所,並通過主管機關查核。通過查核者將核給效期年限,效期屆滿得申請展延;效期期間如經不定期查核為不通過之情形,同時終止委託該場所之醫療機構施行相關細胞治療項目。</span></span></li> </ul> <p><span style="font-size:14px;"><span style="font-family:微軟正黑體;">衛福部食藥署表示,已完成研擬「再生醫療製劑管理條例草案」(原:細胞及基因治療管理法草案),並已進入行政院審議階段,該法藉由捐贈者合適性評估、有條件期限許可制度,及加強上市後安全監控等規範之建立,以確保再生醫療製劑之品質、安全性及有效性,維護病人權益,並促進國人發展再生醫療製劑。</span></span></p> <p><span style="font-size:14px;"><span style="font-family:微軟正黑體;">衛福部強調,透過此2項法規之修正與訂定,健全細胞治療技術法規治理環境,階段性開放細胞治療技術,使細胞治療能早日運用於有需要的病人,並透過有效管理,保障病人安全與醫療品質,並可促進我國生技研發與產業發展。</span></span></p> <p>&nbsp;</p> <p><span style="font-size:14px;"><span style="font-family:微軟正黑體;">資料來源:衛生福利部網站<br /> <a href="https://www.mohw.gov.tw/cp-16-43698-1.html">https://www.mohw.gov.tw/cp-16-43698-1.html</a></span></span></p> <p>首頁底圖<br /> 攝影師:<strong>&nbsp;<a href="https://www.pexels.com/zh-tw/@emshuvo-220345?utm_content=attributionCopyText&amp;utm_medium=referral&amp;utm_source=pexels">EmShuvo&nbsp;</a></strong>,連結:<strong>&nbsp;<a href="https://www.pexels.com/zh-tw/photo/1520659/?utm_content=attributionCopyText&amp;utm_medium=referral&amp;utm_source=pexels">Pexels</a></strong></p> <p>&nbsp;</p>

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