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我们能否在不扼杀创新的前提下确保质量?

Can we assure quality without stifling innovation?

作者信息

Miller Linda

机构信息

Foundation for the Accreditation of Cellular Therapy, University of Nebraska Medical Center , Omaha, Nebraska.

出版信息

Stem Cells Dev. 2014 Dec;23 Suppl 1(Suppl 1):66-7. doi: 10.1089/scd.2014.0346.

Abstract

The emergence of regenerative medicine raises new questions about the best ways to ensure the safety and efficacy of stem cell therapies for patients. The Foundation for the Accreditation of Cellular Therapy (FACT) believes minimum requirements for cellular therapy for regenerative medicine will promote patient safety, protect the research environment, and aid in the swift advancement of regenerative therapies from bench to bedside. The standards development process has demonstrated that consensus on minimum requirements advances the field. FACT's accreditation process and newly established "Common Standards for Cellular Therapies" can help meet unmet needs in regenerative medicine that will drive commercialization of new cell therapies.

摘要

再生医学的出现引发了关于确保干细胞疗法对患者的安全性和有效性的最佳方法的新问题。细胞治疗认证基金会(FACT)认为,再生医学细胞治疗的最低要求将促进患者安全、保护研究环境,并有助于再生疗法从实验室迅速走向临床应用。标准制定过程表明,就最低要求达成共识推动了该领域的发展。FACT的认证过程和新制定的“细胞治疗通用标准”有助于满足再生医学中尚未满足的需求,这将推动新细胞疗法的商业化。

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