呼吸器國家隊第一步 沈榮津：開發100台呼吸器原型機 民視新聞網2020年4月29日 俗稱武漢肺炎的COVID-19疫情在全球持續延燒，台灣繼口罩國家隊後，現在呼吸器國家隊也有譜。經濟部在這次特別預算的追加預算案中，追加了5000萬元，已開發呼吸器的原型。部長沈榮津今（29）日赴立院備詢時表示，已經取得相關的醫事規格資料，國內的呼吸器業者也已經表達意願，將先做出100台原型機，並投入驗證。武漢肺炎爆發後，急重症呼吸器的需求大增，但這類呼吸器的生產多由歐美大廠掌握，台灣由於主要生產用以改善睡眠呼吸中止症的陽壓呼吸器，須仰賴進口急重症使用的呼吸器，因此也出現了組成「呼吸器國家隊」來及早因應醫療需求的呼聲。對此，在這次特別預算的追加預算案中，經濟部追加了5000萬元來做侵入式急重症呼吸器原型機開發，沈榮津表示，目前已經取得相關的醫事規格資料，「我們很快來把它完成雛形機」，國內的呼吸器業者也有表達意願，「希望能先做出100台原型機，並投入驗證」，目前初步的團隊已經成型，經濟部也會協助掌握呼吸器技術的廠商，將產能擴展到急重症呼吸器的開發。
中大攜手聯新醫院研發「呼吸器警報系統」提升醫療新能量 桃園電子報 記者謝宜芳2020-04-27 加護病房裏，插管的重症患者生死交關，為讓患者能獲得有效的監測照顧，並減輕醫護人員的工作負擔，由中央大學電機系徐國鎧講座教授和聯新國際醫院吳清平副院長團隊共同研發的智慧型「呼吸器警報系統」，可以精準地提供患者最佳每分鐘通氣量，還有當呼吸參數異常時，可立即作警報提醒，成果獲美中台三項專利之肯定。中央大學表示，新冠肺炎疫情席捲全球，呼吸器日益難求，中央大學與聯新國際醫院共同研發的新一代呼吸器受到醫界矚目。因為病人在呼吸方面的問題通常都非常緊急，在幾分鐘以內若不作出處置，可能會造成極大傷害。然而，由於醫護人員有限，無法全天候地留在每個病人旁觀察呼吸參數，且當呼吸參數發生異常時，通常並不是調整呼吸器的操作設定就能解決。 中央大學表示，該發明提供一種智慧型之呼吸器和警報系統，透過各項生理呼吸異常數據所觸發的警報訊號，以提供醫護人員有效的警報及即時作業管理，如一旦偵測痰音時，影響呼吸時，會發出提醒；另有管路脫離或漏氣等各項條件之警報。徐國鎧表示，根據聯新國際醫院提供的20-30年臨床治療經驗，發現病患最佳每分鐘通氣量都因人而異，而現況醫療使用的呼吸器都是固定無法適應不同病患狀況。以往都是靠呼吸治療師的經驗手動調整，但為更有效監測，該團隊想出了建置自動化控制系統，將臨床的治療經驗結合理論分析，再透過精密的演算法設計，將呼吸器進一步改造，以精準地自動提供患者最佳每分鐘通氣量，讓患者呼吸更加順暢，並提供即時的警報系統。研究專長在伺服馬達控制的徐國鎧，早期曾開發出「智慧型看護系統」，幫助長期卧床的重症病患，找回自主與自尊，在研究中注入更多人性關懷。近年來則專注在呼吸器控制平台的研發上，希望讓病患得到更好的治療，也減輕第一線醫護人員的工作負荷，並讓世界看見台灣的醫療研發能量。
檢驗產業未受關愛 台灣的快篩試劑在那裡？ 2020-05-02 10:06聯合報 記者陳雨鑫／台北即時報導 想像歐、美等國解封、恢復航線後，我們該如與之恢復往來?在疫苗問世前，許多人把希望放在「快篩檢驗試劑」的研發，誰能先研發出靈敏度、專一性高的快篩試劑，能夠讓新冠肺炎像流感一樣可以透過快篩檢測，就能搶下先機。不過，新冠病毒快篩試劑的研發，仍面臨許多障礙。目前各國使用的檢驗試劑皆以核酸檢測為主，檢驗新冠病毒基因序列片段來確定是否被感染，靈敏度高，缺點是需耗費三到四小時，寶齡富錦生技發言人丁爾昆說明，雖然已有一小時就有結果的產品上市，大家仍寄望只需十五分鐘就明結果的抗原檢測試劑。但目前全球都還沒有找到靈敏度、專一性都高的抗原檢測試劑。永加利醫學科技董事長瞿志豪說，各界雖對快篩試劑寄與厚望，但抗原檢測必須體內病毒量每西西血液達到十的六次方以上，患者於潛伏期就會呈現偽陰性。目前各國面臨的挑戰大同小異，到底COVID-19產生出的抗體蛋白質是哪一款，全世界都抓不準，但中研院三月中旬發表的COVID-19抗原，被學界認為極具代表性，若是臨床試驗成功，將有機會量產，可望率先開發高靈敏度、專一性高的抗原試劑，讓台灣有機會在快篩檢驗試劑的戰爭中脫穎而出。食藥署醫粧組研究員王兆儀說，設置綠色通道後，食藥署成立專案輔導團隊，提供即時諮詢，截至昨天為止，我國已輔導案件達五十件，有八件提出申請，今天也通過首件國產核酸檢驗試劑。王兆儀表示，該款核酸檢驗試劑，從採檢到結果為85分鐘，業者已完成臨床試驗，檢驗試劑的敏感度與特異性都超過95％，今通過後，即起可以專案製造；另外針對專案輸入的案件，目前已經核准9件。王兆儀說，目前業界最困擾的應是台灣確診者少，檢體取得相對困難，國衛院成立「病毒技術分析平台」之後，可媒合業界與醫院，盼能協助開發試劑。食藥署則開放綠色通道，在臨床前試驗開放使用模擬檢體，但業者仍須與收治確診病患的醫院合作，產品必須要交替檢測，通過五陰五陽的確效，才能通過許可。瞿志豪說，食藥署的綠色通道比照美國食藥局，現階段台灣檢驗試劑面臨的挑戰，仍是民間的檢驗量能本身才有機會突破。我國檢驗產業長年以來並未受政府大力扶植，現在要補足民間的檢驗產業能力，除了政府要給足資源，也要看產業多久以後能把技術學起來，展開研發。
Clinical Trials Of Mesoblast's Stem Cell Treatment For COVID-19 Set To Begin Soon
Alex Knapp Forbes Staff, May 2, 2020 Mesoblast's stem cells replicating during the manufacturing process. Melbourne-based biotech company Mesoblast announced earlier this week that it's begun enrolling up to 300 patients for a randomized, controlled study of its stem cell therapy remestemcel-L in the treatment of COVID-19 patients experiencing acute respiratory distress syndrome. Over 20 hospitals will participate in the study, which is anticipated to last 3-4 months. The announcement came about a week after the company reported that treatment with remestemcel-L in a group of 12 COVID-19 patients with ARDS at Mt. Sinai hospital in New York had a survival rate of 83%. The purpose of the randomized, controlled clinical trial is to test that survival rate on a larger scale."We were very pleased with preliminary data demonstrating the cells seem to have benefitted some of these patients," says CEO Silviu Itescu. "If the cells work in COVID-19 ARDS, we're in a position to provide products to as many patients as possible." For coronavirus patients, ARDS is one of the deadliest complications of the disease, and often ends up requiring the use of ventilators in order to ensure they're getting sufficient oxygen. It's caused by what's known as a "cytokine storm" - an overreaction of the immune system in which the body ends up damaging the lungs in an attempt to destroy the coronavirus and the lung cells that it has infected."The cytokines these cells make destroy lung tissue," says Itescu. "It's a trade-off being trying to get rid of the virus and trying to limit destruction to your own lung tissue." According to the CDC, between 20-42% of hospitalized COVID-19 patients develop ARDS, with as many as 85% of patients admitted to intensive care having this complication. Among those ICU patients who develop ARDS, over 40% die (some studies show that number as high as 72%) and those who survive spend an average of 10-13 days in the hospital. Mesoblast's remestemcel-L treatment is derived from allogenic mesenchymal stem cells, which when infused into the body can slow down an immune response and prevent the body from damaging itself. Its technology originally spun out of a research collaboration between Columbia University and Australian scientists, leading to the founding of the company in 2004. One of the diseases the company has been working to treat is graft-vs-host disease, a condition that arises in patients who receive bone marrow transplants. In that disease, the donated bone marrow begins to see its new host as "foreign" and directs the immune system to attack it in a manner similar to that of the cytokine storm seen in ARDS. The company is one of several biotech firms aiming to use mesenchymal stem cells as a potential COVID-19 treatment. Cleveland-based Athersys, which is working on stem cell therapies for strokes, heart disease and other conditions, is also expected to begin clinical trials soon. Haifa, Israel-based Pluristem, which is developing stem cell treatments as well, secured 50 million Euro (about $55.4 million) in financing this week from the European Investment Bank to support its COVID-19 trials. So far, says Itescu, Mesoblast's treatment has been tested in clinical trials in over 1,100 graft-vs-host patients. On April 1, the FDA accepted a priority review filing for use of the treatment against graft-vs-host disease. On April 6, the FDA gave clearance for an investigational new drug application for remestemcel-L in COVID-19 patients, which paved the way for this clinical trial. Using Mesoblast's treatment for coronavirus patients with ARDS "has a rationale behind it" says Dr. Wayne Marasco, who's studied a number of coronavirus diseases and is currently researching potential antibody treatments for COVID-19. "That would be in line with how it works with graft-versus-host disease." Itesecu says that his company is focused on the next phase of its clinical research in the midst of this pandemic, and hopes it proves to be part of a number of effective therapies against the disease."We're going to do our best to provide a solution to those patients in greatest need: those who are in intensive care on ventilators, where I think a safe and effective way to reduce severe inflammation is needed," says Itescu. "We hope that what we're doing is complementary to what folks who are developing vaccines and antivirals are doing."
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