Is cosmetic platelet-rich plasma a drug to be regulated by the Food and Drug Administration?

被引：6

作者：

Centeno, Christopher J. ^{[1
]}

Fuerst, Mitchell ^{[1
]}

Faulkner, Stephen J. ^{[1
]}

Freeman, Michael ^{[1
]}

机构：

[1] Centeno Schultz Clin, Broomfield, CO 80021 USA

来源：

JOURNAL OF COSMETIC DERMATOLOGY | 2011年 / 10卷 / 03期

关键词：

grafting; regulatory affairs; safety; MESENCHYMAL STEM-CELLS; ADIPOSE-TISSUE;

D O I：

10.1111/j.1473-2165.2011.00575.x

中图分类号：

R75 [皮肤病学与性病学];

学科分类号：

100206 ;

摘要：

In the area of cosmetic dermatology, some physicians have been injecting activated platelet-rich plasma into the face to promote cosmesis or using it to enhance fat grafts. However, subtle changes to the federal drug code (21 CFR 1271.1) made in 2004, when applied to activated PRP, purport to make this autologous substance a federally regulated drug requiring an extensive and costly Biologics License Application. Are autologous cells drugs? Many physicians believe there are significant problems with this regulatory paradigm.

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页码：171 / 173

页数：3

相关论文

共 17 条

[1] Autologous fibrin matrices: A potential source of biological mediators that modulate tendon cell activities [J].

Anitua, E ;

Sanchez, M ;

Nurden, AT ;

Zalduendo, M ;

de la Fuente, M ;

Orive, G ;

Azofra, J ;

Andia, I .

JOURNAL OF BIOMEDICAL MATERIALS RESEARCH PART A, 2006, 77A (02) :285-293

[2]

[Anonymous], 2008, GUID HUM CELL BAS ME

[3]

Cervelli V, 2009, TISSUE ENG PART C-ME, V15, P625, DOI [10.1089/ten.tec.2008.0518, 10.1089/ten.TEC.2008.0518]

[4] Autologous Platelet-Rich Plasma Mixed with Purified Fat Graft in Aesthetic Plastic Surgery [J].

Cervelli, Valerio ;

Palla, Ludovico ;

Pascali, Michele ;

De Angelis, Barbara ;

Curcio, Beniamino C. ;

Gentile, Pietro .

AESTHETIC PLASTIC SURGERY, 2009, 33 (05) :716-721

[5] Concise review: Mesenchymal stem cells: Their phenotype, differentiation capacity, immunological features, and potential for homing [J].

Chamberlain, Giselle ;

Fox, James ;

Ashton, Brian ;

Middleton, Jim .

STEM CELLS, 2007, 25 (11) :2739-2749

[6]

*D O H A H SERV, 1982, US APPR DRUGS UNL IN

[7] FDA regulation of stem-cell-based therapies [J].

Halme, Dina Gould ;

Kessler, David A. .

NEW ENGLAND JOURNAL OF MEDICINE, 2006, 355 (16) :1730-1735

[8]

Lacci Kathleen M., 2010, Yale Journal of Biology and Medicine, V83, P1

[9] Effects of calcium and thrombin on growth factor release from platelet concentrates: Kinetics and regulation of endothelial cell proliferation [J].

Martineau, I ;

Lacoste, E ;

Gagnon, G .

BIOMATERIALS, 2004, 25 (18) :4489-4502

[10] Platelet-Rich Plasma (PRP) Promotes Survival of Fat-Grafts in Rats [J].

Nakamura, Shinichiro ;

Ishihara, Masayuki ;

Takikawa, Megumi ;

Murakami, Kaoru ;

Kishimoto, Satoko ;

Nakamura, Shingo ;

Yanagibayashi, Satoshi ;

Kubo, Satoshi ;

Yamamoto, Naoto ;

Kiyosawa, Tomoharu .

ANNALS OF PLASTIC SURGERY, 2010, 65 (01) :101-106