US clinics marketing unproven and unlicensed adipose-derived autologous stem cell interventions

Regenerative Medicine

Volumn 10, Issue 4, 2015, Pages 397-402

  Turner, Leigh G ^a  

^a UNIVERSITY OF MINNESOTA   (United States)

Author keywords

adipose derived mesenchymal stromal cells; marketing claims; patient safety; US FDA

Indexed keywords

ADIPOSE DERIVED STEM CELL; ADULT STEM CELL; ADVERTIZING; AUTOLOGOUS STEM CELL TRANSPLANTATION; DEVICE APPROVAL; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HUMAN; MARKETING; MEDICAL DEVICE REGULATION; MEDICAL TOURISM; MESENCHYMAL STEM CELL TRANSPLANTATION; NOTE; PATIENT SAFETY; PRIORITY JOURNAL; PROCEDURES CONCERNING CELLS; STEM CELL TRANSPLANTATION; STROMAL VASCULAR FRACTION; UNNECESSARY PROCEDURE; ADIPOSE TISSUE; AUTOTRANSPLANTATION; CYTOLOGY; DEVICES; LEGISLATION AND JURISPRUDENCE; PRACTICE GUIDELINE; SOCIAL CONTROL; STEM CELL; STROMA CELL; UNITED STATES;

ADIPOSE TISSUE; EQUIPMENT AND SUPPLIES; GUIDELINE ADHERENCE; HUMANS; MARKETING; SOCIAL CONTROL, FORMAL; STEM CELL TRANSPLANTATION; STEM CELLS; STROMAL CELLS; TRANSPLANTATION, AUTOLOGOUS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84930368029     PISSN: 17460751     EISSN: 1746076X     Source Type: Journal    
DOI: 10.2217/rme.15.10     Document Type: Note

References (21)

1. Sipp D. The unregulated commercialization of stem cell treatments: a global perspective Front. Med. 5, 348-355 (2011).
2. Lau D, Ogbogu U, Taylor B, Stafinski T, Menon D, Caulfield T. Stem Cell Clinics Online: the direct-toconsumer portrayal of stem cell medicine. Cell Stem Cell 3, 591-594 (2008).
3. Cyranoski D. Patients seek stem-cell compensation. Nature News Blog (2012). http://blogs.nature.com
4. Amariglio N, Hirshberg A, Scheithauer B et al. Donor-derived brain tumor following neural stem cell transplantation in an ataxia telangiectasia patient. PLoS Med. 6 (2), e1000029 (2009).
5. Dolgin E. Letter campaign sought to pressure FDA action on stem cell clinics. Nat. Med. 20, 796-797 (2014).
6. Lysaght T, Campbell A. Regulating autologous adult stem cells: the FDA steps up. Cell Stem Cell 9, 393-396 (2011).
7. Lau D, Ogbogu U, Taylor B, Stafinski T, Menon D, Caulfield T. Stem Cell Clinics Online: the direct-toconsumer portrayal of stem cell medicine. Cell Stem Cell 3, 591-594 (2008).
8. Obgogu U, Rachul C, Caulfield T. Reassessing direct-toconsumer portrayals of unproven stem cell therapies: is it getting better? Regen. Med. 8, 361-369 (2013).
9. Buckler L. Point-of-care cell processing technologies: what's in clinical use in the U.S. ISCT North American Regional Meeting, Philadelphia, PA, USA, (2013). http://c.ymcdn.com
10. Food and Drug Administration, Warning Letter to Melbourne Kimsey II, President, CEO, Medical Device Resource Corporation (2012). www.fda.gov
11. Knoepfler P. Elliot Lander & Mark Berman Interview Part 1: A Window into Cell Surgical Network, Knoepfler Lab Stem Cell Blog, (2013). www.ipscell.com
12. Turner L. Precision Stem Cell, (2012). www.scribd.com
13. Aronowitz J, Ellenhorn J. Adipose stromal vascular fraction isolation: a head-to-head comparison of four commercial cell separation systems. Plast. Reconstr. Surg. 132 (6), e932-e939 (2013).
14. Morrison D, Hunt D, Garza I, Johnson R, Moyer M. Counting and processing methods impact accuracy of adipose stem cell doses. BioProcess. J. 11 (4), 4-17 (2012).
15. Food and Drug Administration, Warning letter to Thomas E. Young, MD, Owner and Director, Young Medical Spa (2012). www.fda.gov
16. Food and Drug Administration, Warning letter to Dr. Steven Victor, Chief Executive Officer, Intellicell Biosciences, Inc. (2012). www.fda.gov
17. Food and Drug Administration, Warning letter to David G. Eller, Chief Executive Officer and President, CellTex Therapeutics Corporation (2012). www.fda.gov
18. 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
19. 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
20. 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
21. ASAPS/ASPS Position Statement on Stem Cells and Fat Grafting. Aesthet. Surg. J. 31, 716-717 (2011).