Scientometrics | United States America (US)

Create: 2025-02-05 Update: 2025-06-27 22:35:10

اولین مطالعه‌ی کارآزمایی بالینی برای پیوند عضو از خوک به انسان (xenotransplants)، مجوز سازمان غذا و داروی آمریکا را دریافت کرد و مطالعه امسال شروع خواهد شد.

در این مطالعه شش بیمار (ESRD)، از خوک کلیه دریافت می‌کنند که از نظر ژنتیکی اصلاح شده‌اند تا احتمال رد پیوند کمتر باشد. بیماران ابتدا برای شش ماه از نظر عوارض جدی، بیماریهای عفونی و علائم آسیب به کلیه به شکل دقیق تحت نظر قرار می‌گیرند و سپس تا آخر عمر پیگیری می‌شوند. تاثیرگذاری این روش نیز با بررسی بقای فرد و کلیه پیوندی بررسی می‌شود.

سازمان غذا و دارو دستور داده است که بین پیوند هر بیمار وقفه‌ای ایجاد شود تا از بروز مشکلات غیرمنتظره جلوگیری شود. یک کمیته داده‌های مربوط به ایمنی و اثربخشی را برای شش بیمار اول بررسی خواهد کرد و سپس در مورد ادامه مطالعه برای وارد کردن حداکثر ۵۰ نفر در مطالعه تصمیم‌گیری می‌شود.

دریافت عضو از خوک اصلاح ژنتیکی شده قبلا برای حدودا شش نفر انجام شده بود و همگی به صورت موردی تائیدیه (compassionate) داشتند. این موارد در آمریکا و چین برای پیوند کلیه، کبد، قلب و تیموس انجام شده بود. در نهایت اکثر آنها به دلایلی همچون عدم تحمل جراحی بزرگ به علت بیماری شدید، بیش از چندماه زنده نمانده بودند.

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اولین مطالعه‌ی کارآزمایی بالینی برای پیوند عضو از خوک به انسان (xenotransplants)، مجوز سازمان غذا و داروی آمریکا را دریافت کرد و مطالعه امسال شروع خواهد شد.

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