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ステムリムグループ、レダセムチド第1/2相臨床試験の被験者登録を完了

-- ステムリムグループ (TYO:4599) は、虚血性心筋症に対する再生医療候補薬レダセムチドの第1/2相医師主導臨床試験において、患者登録を完了した。

大阪大学病院を中心とする5施設で実施されたこの試験には、冠動脈バイパス手術を受けた患者14人が登録され、参加者は5日間、レダセムチドまたはプラセボを投与された。

主要評価項目は、薬剤の安全性と忍容性の評価であり、有効性は投与後52週目に実施される心機能検査によって評価される。

ステムリムは、登録患者数は当初計画の20人を下回ったものの、試験全体の進捗状況に基づき、主要評価項目を評価するには十分であると判断した。

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