発血性心不全患者のためのイックスミエロセル-T: 予備的なランダム化二重盲検試験
Amit N Patel1, Timothy D Henry2, Arshed A Quyyumi3
1University of Utah Health Care, Salt Lake City, UT, USA.
Lancet (London, England)
|April 10, 2016
まとめ
Ixmyelocel- T細胞治療は,心不全の患者で心的イベントを著しく減少させました. この拡張された多細胞治療は,これまでに実施された最大の心不全細胞治療試験で,患者の治療結果を改善しました.
科学分野:
- 心臓病科
- 再生医療
- 細胞療法
背景:
- Ixmyelocel- Tは患者の骨髄から得られた拡張された多細胞療法です.
- CD90+ メゼンキマ幹細胞とCD45+ CD14+ 活性化マクロファージの選択的な拡張を伴う.
- 以前の臨床試験では,心不全で発血性伸縮性心筋病気が発症した患者の治療に有益な可能性があることが示された.
研究 の 目的:
- イクスミエロセル-Tのカテーテルによるトランスエンドカーディアル注射の安全性と有効性を評価する.
- 心不全とイシェイミック・ディラテッド・カルディオパシーによるエジェクション・フラクションの減少による患者のアウトカムを評価する.
主な方法:
- 126人の患者が参加したランダム化,ダブルブラインド,プラセボ対照フェーズ2B試験 (ixCELL- DCM).
- 患者はイックスミエロセルTまたはプラセボを投与し,12ヶ月間追跡した.
- 主なエンドポイントは,死亡,心血管疾患の入院,急性無補償性心不全の予定外訪問の組み合わせでした.
主要な成果:
- プラセボと比較して,イクスミエロセルT群では心臓発作が37%減少した (リスク比0. 63; p=0. 0344).
- 重篤な有害事象は,イクスミエロセルT群では,プラセボ群の75% (p=0. 0197) と比べて,より少なく見られた.
- この研究では,NYHAクラスIII/ IVの心不全と,リバスカライゼーションの資格のないLVEF≤35%の患者が含まれていました.
結論:
- Ixmyelocel- Tのトランスエンドカーディアル投与は,心不全患者の臨床心疾患を有意に減少させた.
- これまでのところ,心臓不全患者で実施された最大の細胞治療試験です.
- ixmyelocel- T療法により患者のアウトカムが改善されたことが示唆されています.
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