Artigo Revisado por pares

Us Clinics Marketing Unproven and Unlicensed Adipose-Derived Autologous Stem Cell Interventions

2015; Future Medicine; Volume: 10; Issue: 4 Linguagem: Inglês

10.2217/rme.15.10

ISSN

1746-076X

Autores

Leigh Turner,

Tópico(s)

Science, Research, and Medicine

Resumo

Regenerative MedicineVol. 10, No. 4 CommentaryUS clinics marketing unproven and unlicensed adipose-derived autologous stem cell interventionsLeigh G TurnerLeigh G TurnerCenter for Bioethics, School of Public Health & College of Pharmacy, University of Minnesota, N520 Boynton, 410 Church Street SE, Minneapolis, MN 55455, USA E-mail Address: turne462@umn.eduPublished Online:29 May 2015https://doi.org/10.2217/rme.15.10AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInReddit View articleKeywords: adipose-derived mesenchymal stromal cellsmarketing claimspatient safetyUS FDAReferences1 Sipp D. The unregulated commercialization of stem cell treatments: a global perspective. Front. Med. 5, 348–355 (2011).Crossref, Medline, Google Scholar2 Lau D, Ogbogu U, Taylor B, Stafinski T, Menon D, Caulfield T. Stem Cell Clinics Online: the direct-to-consumer portrayal of stem cell medicine. 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Young, MD, Owner and Director, Young Medical Spa (2012). www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm301620.htm.Google Scholar16 Food and Drug Administration, Warning letter to Dr. Steven Victor, Chief Executive Officer, Intellicell Biosciences, Inc. (2012). www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm297245.htm.Google Scholar17 Food and Drug Administration, Warning letter to David G. Eller, Chief Executive Officer and President, CellTex Therapeutics Corporation (2012). www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm323853.htm.Google Scholar18 Food and Drug Administration, Same surgical procedure exception under 21 CFR 1271.15(b): questions and answers regarding the scope of the exception, Draft Guidance for Industry (2014). www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm419911.htm.Google Scholar19 Food and Drug Administration, Minimal manipulation of human cells, tissues, and cellular and tissue-based products, Draft Guidance for Industry and Food and Drug Administration Staff (2014). www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/ucm427692.htm.Google Scholar20 Food and Drug Administration, Human cells, tissues, and cellular and tissue-based products (HCT/Ps) from adipose tissue: regulatory considerations, Draft Guidance for Industry (2014). www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm427795.htm.Google Scholar21 ASAPS/ASPS Position Statement on Stem Cells and Fat Grafting. Aesthet. Surg. J. 31, 716–717 (2011).Crossref, Medline, Google ScholarFiguresReferencesRelatedDetailsCited ByCurrent Good Manufacturing Practice (cGMP) Facility and Production of Stem Cell30 March 2022Public Opinion and Expectations of Stem Cell Therapies in OrthopaedicsArthroscopy: The Journal of Arthroscopic & Related Surgery, Vol. 37, No. 12Rogue stem cell clinicsThe Bone & Joint Journal, Vol. 102-B, No. 2The direct-to-consumer market for stem cell-based interventions in Australia: exploring the experiences of patientsCatherine Waldby, Tereza Hendl, Ian Kerridge, Wendy Lipworth, Tamra Lysaght, Megan Munsie & Cameron Stewart3 February 2020 | Regenerative Medicine, Vol. 15, No. 1Clinicopathologic Correlations of Retinal Membranes Associated With Intravitreal 'Stem Cell' InjectionsOphthalmic Surgery, Lasers and Imaging Retina, Vol. 50, No. 2The involvement of Canadian physicians in promoting and providing unproven and unapproved stem cell interventions2 May 2018 | BMC Medical Ethics, Vol. 19, No. 1An endogenous explanation of growth: direct-to-consumer stem cell therapies in PR China, India and the USASaheli Datta21 August 2018 | Regenerative Medicine, Vol. 13, No. 5Selling stem cell 'treatments' as research: prospective customer perspectives from crowdfunding campaignsJeremy Snyder & Leigh Turner9 July 2018 | Regenerative Medicine, Vol. 13, No. 4Resituating overseas stem cell therapyAmit Prasad2 November 2017 | Regenerative Medicine, Vol. 12, No. 7Stem cells in court: historical trends in US legal cases related to stem cellsAndreia Martins Martinho & Leigh Turner16 June 2017 | Regenerative Medicine, Vol. 12, No. 4Vision Loss after Intravitreal Injection of Autologous "Stem Cells" for AMDNew England Journal of Medicine, Vol. 376, No. 11The Stem Cell Hard Sell: Report from a Clinic's Patient Recruitment Seminar2 August 2016 | Stem Cells Translational Medicine, Vol. 6, No. 1Selling Stem Cells in the USA: Assessing the Direct-to-Consumer IndustryCell Stem Cell, Vol. 19, No. 2The Global Emergence of Unregulated Stem Cell Treatments for Respiratory Diseases. Professional Societies Need to ActAnnals of the American Thoracic Society, Vol. 13, No. 8New ISSCR guidelines: clinical translation of stem cell researchThe Lancet, Vol. 387, No. 10032Uncertain Oversight of Regenerative Medicines in Japan under the ASRMCell Stem Cell, Vol. 18, No. 4Cosmetic Surgery, Aesthetic Surgery, Plastic Surgery1 March 2016 | The American Journal of Cosmetic Surgery, Vol. 33, No. 1 Vol. 10, No. 4 Follow us on social media for the latest updates Metrics Downloaded 341 times History Published online 29 May 2015 Published in print May 2015 Information© Future Medicine LtdKeywordsadipose-derived mesenchymal stromal cellsmarketing claimspatient safetyUS FDAFinancial & competing interests disclosureThe author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending or royalties.No writing assistance was utilized in the production of this manuscript.PDF download

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