我國臍帶血保存與使用現況調查報告   全文下載

Survey on the Preservation and Application of Cord Blood in Taiwan

為確保移植用人體細胞組織物之安全品質，衛生福利部食品藥物管理署（以下簡稱食藥署）依人體器官保存庫管理辦法執行人體器官保存庫之許可管理，其中，臍帶血為納管保存標的物之一。因部分設有臍帶血保存庫之生技公司亦提供民眾自費寄存臍帶血，故衛生福利部另訂有「臍帶血保存定型化契約應記載及不得記載事項」以保障消費者權益。本研究以問卷方式調查與分析國內10家法人公司/基金會及2家醫療機構之臍帶血貯存現況。調查結果顯示，迄2015年全台臍帶血儲存總量約20萬袋，以自費儲存為主，佔總儲存量約79%，公益捐贈僅佔約21%，不論公益或自費儲存收案量皆逐年減少。目前我國臍帶血於移植醫療之臨床應用主要用於急性淋巴性白血病、急性骨髓性白血病及重度乙型地中海貧血等疾病，其使用公益捐贈之臍帶血佔82%，為主要來源。本調查亦顯示，機構藉由與國外相關臍帶血及骨髓資料庫之配對平台或醫院合作方式，可增加其配對成功案例。本次調查結果，提供衛生福利部規劃建置全國臍帶血資訊登錄平台之參考，以期提高國人使用臍帶血的配對成功率。食藥署亦持續辦理教育宣導，協助民眾正確認知臍帶血保存及其風險，並透過臍帶血庫之許可管理確保我國臍帶血儲存之安全與品質。

In order to ensure safety and quality of human tissues and cells for transplantation, the Taiwan Food and Drug Administration (TFDA) is responsible for issuing and maintenance the authorization of tissues/ cells banking establishments. A cord blood bank should be licenced and regulated by TFDA as well. In addition, to protect the interests of those parents who preserve their baby's cord blood in a private bank, a contract between parents and the private bank must be established and comply with the regulation on'' Mandatory and prohibition provisions of standard contract for umbilical cord blood preservation '' published by Ministry of Health and Welfare (MOHW). This study is aimed at analysis the status quo of cord blood banking in Taiwan by conduct a questionnaire survey of 12 cord blood banks. The survey results show that there is totally about 200,000 units of cord blood had been preserved. Among them, 79% were banked by the parents with a private cord blood, only 21% were donated. The case of cord blood banking of both donated and private preserved are decreasing year by year. In Taiwan, the cord blood is mainly used to treat patients with cancers such as leukemia and lymphoma and other disorders of blood and immune system, and 82% of cord blood used from the donation. The outcome of this survey also shows that the use and matching successful rate would be increasing if the bank cooperates with other national and international institutes or associate of data banking of donors for haematopoietic stem cells source. The outcome of this survey provides the useful information for MOHW to further planning on building up the National Cord Blood Inventory. TFDA is committed to ensure the safety and quality of cord blood banking, to protect the consumer and promote the industrial upgrading.