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テラ(株)【2191】の掲示板 2020/08/02

  • >>279

    自動翻訳は英語の方が正確なので載せておきます。まず重要なのは第四段落で、治療法を認めたことは(これまでまだ)無いとあります。今後も認めないとは書いていません。次に最終段落、有効性が結論付けられていない治療法を使わないようにと読めます。
     これまで開発されてきた数々の治療法を効きそうだからと勝手に使わないようにということです。勝手な適用への警告です。
     今後申請されたものを受理しないとは書かれていないし、承認しないとも書かれていません。
     ちなみにプロジェクトは州保健局の承認のもとで治験し、結果を提出して薬事申請したのはご存知の通り。連邦政府保健省との調整に入っているのではと想像します。

    The Federal Commission for the Protection against Sanitary Risks (Cofepris) reports that the application of stem cells for several years is in studies to demonstrate safety and efficacy in different promising therapies, various clinical protocols around the world have been approved under the rigor of best clinical and research practices.

    The development of health research must address ethical and scientific aspects that guarantee the dignity and well-being of the person subject to research and must comply with technical criteria and clear guidelines to regulate the application of procedures related to its proper development, be evaluated and approved by the ethics committee of the institution in which it is practiced.

    In the context of the global pandemic caused by COVID-19, a large number of fraudulent therapies based on the application of stem cells have emerged internationally, without the support of results supported by developed clinical studies, under scientific rigor.

    In this context, it is made known to the entire medical community that Cofepris has not authorized any Clinical Protocol that supports treatment or therapy based on Stem Cells.

    Therefore, this Federal Commission urges the medical community not to use this or any other treatment or therapy that is associated with the cure of the disease or symptoms caused by COVID-19, which does not have conclusive clinical studies on the positive effects in the reduction or elimination of the disease or its symptoms.