美国干细胞诊所、患者安全和 FDA
US stem cell clinics, patient safety, and the FDA.
机构信息
Center for Bioethics, School of Public Health, University of Minnesota, N520 Boynton, 410 Church Street South East, Minneapolis, MN 55455, USA.
出版信息
Trends Mol Med. 2015 May;21(5):271-3. doi: 10.1016/j.molmed.2015.02.008.
Scholarship on patients accessing unproven stem cell interventions is dominated by research addressing 'stem cell tourism' to such countries as China, India, Mexico, and the Ukraine. However, clinics marketing 'adipose-derived mesenchymal stem cell treatments' are proliferating across the USA. These businesses typically claim to operate in compliance with federal regulations, but careful review of their commercial practices suggests that such clinics are marketing unapproved and noncompliant biological drugs.
关于患者接受未经证实的干细胞干预的研究主要集中在“干细胞旅游”方面，涉及中国、印度、墨西哥和乌克兰等国家。然而，在美国，营销“脂肪来源间充质干细胞治疗”的诊所正在激增。这些企业通常声称其运营符合联邦法规，但仔细审查其商业行为表明，这些诊所正在推销未经批准和不合规的生物药物。
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