臺灣地區醫政單位開放合法幹細胞治療及其它 臨床用途之政策暨傾向探討

Abstract

幹細胞的運用始於西元第八世紀，直到近代十九世紀，幹細胞研究進入一個全新的里程碑。結合現代醫學技術與各先進國家優秀的臨床與基礎醫學，醫學技術，藥學，牙醫學，材料工程，分子生物學，生物科技，生物醫學各領域的專家學者日以繼夜的努力之下，近代幹細胞技術廣泛利用了自體成人幹細胞，異體成人幹細胞，異體異種幹細胞，再加上HLA Typing 的技術成熟，對因異體或異體異種幹細胞移植所致之幹細胞排斥疾病GvHD 的充分了解，利用基因轉植，幹細胞的配合療法，甚至幹細胞組織工程的漸趨成熟，越來越多大型動物與人體臨床實驗的成功，許多當代醫學視為無法救治的疾病在神奇的幹細胞的幫助下痊癒，恢復，進步的新聞一次又一次展現在世人面前。世人對幹細胞充滿期待。在臺灣積極發展生技的同時，必需有適當的法源，政策與之配合才能打造臺灣為生技島，生技產業是否會成功取代電子產業而讓臺灣由電子產業島成功變成生技產業島，而幹細胞發展是否會被列入臺灣優先發展與獎勵的生技項目，就端賴政府的政策與方向。本文以質性法，以產官學取樣，深度訪談法，最後做出結論， 就本文研究交叉比對，不分產，官，學受訪者就本文研究議題所得之綜合結論如下:(1).就幹細胞會否發展成主流醫學的一部分?受訪者的答案為清楚確定幹細胞會否發展成主流醫學的一部分佔百分之83.4， 清楚否定幹細胞會否發展成主流醫學的一部分0%，不確定細胞會否發展成主流醫學的一部分佔百分之16.6。(2).自體或異體幹細胞間何者會發展成為主流幹細胞醫學? 受訪者的答案為清楚確定自體幹細胞會否發展成主流幹醫學的佔百分之50，認為二者皆可能佔百分之50。(3).(3.1).對臺灣目前幹細胞技術水準之看法? 受訪者的答案為清楚確定臺灣目前幹細胞技術水準達國際水平者佔 0%， 認為臺灣目前幹細胞技術水準不足以達到國際水平者佔100% ，不確定者佔0%。(3.2)以及目前臺灣幹細胞發展水平是否急需引進國外先進技術 ? 受訪者的答案為清楚確定臺灣目前急需引進國外先進技術者佔100%， 認為不需要者佔0% ，不確定者佔0%。(4).(4.1)對臍帶 iv血幹細胞儲存的看法? 認為臍帶血幹細胞儲存深具意義者佔 0%，認為不太具有意意者佔 100%， 不清楚者佔 0%。 (4.2).該事業之前景?認為前景極好者佔0%，前景不佳者100%，不清楚佔0%。(5).國際上成人自體幹細胞儲存與治療技術之引進臺灣?應該引進臺灣者佔100%，不應該者0%，不確定0%。 (6).認為我國之幹細胞政策應朝哪個方向發展?認為應該有條件開放者100%，認為應該緊縮政策者0%，沒意見0%。(7). (7.1)是否應將發展生技列為重要施政重點?認為 應該將發展生技列為重要施政重點者佔83.4%，不應該0%，不確定16.6%。(7.2)我國是否應優先發展與獎勵成人幹細胞技術?認為應優先發展與獎勵成人幹細胞技術佔41.55%，不應該者佔8.7%，不確定49.8%。 (8). 是否支持未來將自體幹細胞治療列入健保給付?支持83.34%，不支持0%，有條件支持16.66%。希望此結論能做為執政者，相關產官學專業，醫政，生技，生醫相關單位，官員，有志 投入生技，生醫產業，醫學界，幹細胞學界之參考與指正。

The Clinical appliance of Stem Cells started from 8th century, meanwhile the Research went to a new mile stone since from 19th century. The continues research combine with lots of experts, clinicians, professors, technologists of Clinical Medicine, Basic Medicine, Medical Technology, Pharmacology, Dentistry, Material Engineering, Molecular Biology, BioTechnology, Bio Medicine of different fields from different countries has been developing day after day. Modern Technology of Stem Cells widely use Adult Autologus, Allogeneous, Xenogeneous Stem Cells add the mature technique of HLA-typing and the well understanding of GvHD which caused by Allogeneous, Xenogeneous Stem Cells implantation, More and more large scaled animal or Human Clinical Trials were successfully practiced under using the getting matured technique of Genes transplantation,combined therapy of Stem Cells and or Tissue Engineering of Stem Cells. More and more news were broadcasted in front of people which revealed many diseases which could not be cured under so called Current Medical Care werecured ,getting improved, recovered under the aid of Stem Cells .The heart of people full filled of hope to Stem Cells. We must have the vi combination of reasonable and sufficient laws, rulings ,and policies to make Taiwan as the island of Bio technology while the government of Taiwan develop Bio technology strongly. Whether the IT industry will be replaced by the industry of Bio technology which make Taiwan become the island of Bio technology industry, and it depend on the orientations and policies of the government as the developing of Stem Cells will be listed as the focus and superior or rewarded item of Biotechnology. The Research use the Qualitative Researching methods which select many interviewers belong to certain manufacturing ,government ,and professions to interviewed by the methods of In-depth interview. Finally the conclusion was made according to the analysis of the research. We do the cross comparison and analysis of the interviewers without the classification of their occupation of the research . The generalized conclusion of the research as like the following items: they are (1). If the Stem Cells Research will become one part of Main stremed Medicine? Yes: 83.4 %, No: 0% ,Not sure: 16.6%. (2). Wheather Autologus or Allogeneous Stem Cells will become the Main Streamed Ste, Cells Research? Autologus:50 %, Allogeneous:50%.(3).(3.1).The standard of Taiwan Stem Cells Research ? Has reached the international standard: 0%, Not yet reached the international standard: 100%,Not sure: 0%.(3.2)Does Taiwan need import the advanced Stem Cells technique overseas? Yes:100%,No:0%,Not sure: 0%. (4).(4.1) Concepts to the Umbilical Cord Blood vii Storage in Taiwan? Meaningful:0%, Not too meaningful:100%, Not clear:0%.(4.2).Futuring of the Umbilical Cord Blood storage in Taiwan ? Good futuring: 0%,Not good futuring: 100%, Not clear:0%. (5).Imported International technique of Adult Stem Cells of storage and treatment to Taiwan? Need: 100%,No need:0%,not clear:0%/. (6).What orientation should be adopted to the Stem Cells policies? Opened under certain qualifications: 100%, Policies should be restricted:0%, no comments: 0%. (7).(7.1)Should Taiwan government treat Bio-technique industries as the first priority of the government policies ? Yes: 83.4%, No:0%,not clear: 16.6%. (7.2) Should Taiwan government treat and reward the research of Stem Cells as the first priority of her policies? Yes: 41.55%, No: 8.7%, not sure: 49.8%. (8). Do you agree with adoption Stem Cells treatment to the payment of generalized health insurance in Taiwan? Yes: 83.34, No: 0%, Yes under certain situations: 16.66%. Hopefully, the result can be treated as the main resource to the related officials, decisions makers, certain persons of professions of medical, Bio medical, Stem cells research, medical policies, related fields of industries.