Professional Documents
Culture Documents
Perspective
For reprint orders, please contact: reprints@futuremedicine.com
Stem cell research has attracted an extraordinary amount of attention and expectation due to its potential
for applications in the treatment of numerous medical conditions. These exciting clinical prospects have
generated widespread support from both the public and private sectors, and numerous preclinical studies
and rigorous clinical trials have already been initiated. Recent years, however, have also seen alarming
growth in the number and variety of claims of clinical uses of notional ‘stem cells’ that have not been
adequately tested for safety and/or efficacy. In this article, I will survey the contours of the stem cell
industry as practiced by alternative medicine providers, and highlight points of commonality in their
strategies for marketing.
KEYWORDS: alternative medicine n cosmetics n fresh cells n nutraceuticals n stem cell Douglas Sipp
applications n stem cell tourism RIKEN Center for Developmental
Biology, 2–2-3 Minatojima
Minamimachi, Chuo-ku, Kobe,
Alternative medicine is broadly defined as the stem cells, and in recognition of the wide range 650-0047, Japan
set of healthcare practices that falls outside of of assertions made by many such practices that Tel.: +81 783 063 043
Fax: +81 783 063 990
the mainstream of established medical practice range from therapeutic applications to poorly sipp@cdb.riken.jp
in a given country or culture [101] . An equally defined improvements in wellbeing, appearance
important defining characteristic, however, and and vitality.
one that I will use in this article, is reliance on Alternative medicine, and the related realms
speculation, anecdote and appeals to authority, of complementary, holistic and integrative medi-
rather than evidence from rigorously designed cine, encompass a wide range of approaches
scientific experiments to support claims. to healthcare, including practices adapted
Indeed, in an influential editorial, the editors from Chinese, Indian, Native American, and
of the New England Journal of Medicine based European folk medicine, homeopathy, chiro-
their own definition on evidentiary standards, practic medicine, naturopathy, aromatherapy,
calling alternative medicine the set of health- crystal therapy, herbal supplements, nutrient
care practices that has “not been scientifically megadoses, biofeedback, electric and magnetic
tested and [whose] advocates largely deny the therapies, and faith healing. These approaches
need for such testing” [1] , which was echoed in are distinguished from evidence-based medi-
a statement by the editors of the Journal of the cine in that either their therapeutic claims for a
American Medical Association, which went so wide range of conditions have been tested and
far as to repudiate the distinction: “There is no found to be no more effective than placebo, or
alternative medicine. There is only scientifically they have not been subject to any rigorous stud-
proven, evidence-based medicine supported by ies of safety and efficacy [3,4] . Given the diverse
solid data or unproven medicine, for which sci- nature of the approaches categorized as alterna-
entific evidence is lacking” [2] . For the purposes tive medicine, it has proven difficult to develop
of this article, I define ‘alternative medicine’ reliable figures on usage and market size, but it
as any purportedly therapeutic approach that has been estimated that between 30 and 50%
is not validated by, or which does not seek to of all Americans use at least one alternative or
attain, rigorous scientific evidence for its claims complementary treatment, giving a total market
prior to offering them commercially. The areas size of over US$40 billion [5,6] .
of wellness, cosmetics, esthetics and quality of I will argue that untested and under-regulated
life, which are typically subject to less rigorous uses of ‘stem cells’ represent a new and increas-
testing and regulation than medical products, ingly popular class of alternative medicine prod-
fall into the same spectrum of poor evidentiary ucts. The marketing of these nostrums relies on
support, and have here been classed together claims that such products use, mimic, activate
with alternative medicines to illustrate the diver- or enhance stem cell functions for medicinal,
sity of untested claims surrounding the use of cosmetic, anti-aging or other quality-of-life
10.2217/RME.11.13 © Douglas Sipp Regen. Med. (2011) 6(3), 407–414 ISSN 1746-0751 407
Perspective Sipp
purposes. It is important to note that in the of claims regarding the types of cells used,
great majority of instances, it is impossible to methods of delivery and conditions treated.
determine whether the substances that are being A scan of English-language websites reveals
used in these alternative treatments are com- unsupported claims for therapeutic uses of
posed entirely of, or even contain, bona fide stem bone marrow cells [104] , umbilical cord blood
cells, and that in a great many cases, such as cells [105] , adipose-derived stem cells [106] , olfac-
alleged applications of injected human embry- tory ensheathing glial cells [107] , fetal stem cells
onic [201] or induced pluripotent stem cells [102] [108,109] , embryonic stem cells [110] and, in at least
(which would be associated with a significant one case, induced pluripotent stem cells [102] .
risk of tumor formation), they clearly do not. Cell solutions may be delivered intravenously,
For this reason, I would like to emphasize that or in situ into tissues including spinal cord,
in using the term ‘stem cell(s)’ in the present peritoneum, myocardium and brain.
article, I am referring to claims made by the The range of therapeutic claims varies by
advertisers of such products, and that the true provider, but these tend to cluster around
identity of the material in question is unverified, neurologic, metabolic, cardiovascular and auto
and should be treated as such. immune disorders. One list maintained by the
Alternative medical uses of the stem cell Repair Stem Cell Institute claims that somatic
concept (meaning those that have not been stem cells of various types are effective in the
subjected to rigorous testing for safety and treatment of more than 180 conditions [111] .
efficacy) can be categorized roughly into one Beike Biotechnology includes more than 80
of four varieties: putative therapeutic uses of diseases and traumas among its “treatable con-
human ‘stem cells’; ‘fresh’ or ‘live’ cell treat- ditions” [105] . EmCell, a “fetal stem cell” clinic
ments using lyophilized animal cells; nutritional in Russia lists around 70 [109] . Geeta Shroff, an
supplements that purport to enhance endo Indian obstetrician who uses “embryonic stem
genous stem cell function, or to contain stem cells” at her clinic in Delhi filed a patent claim-
cell extracts; and cosmetic products claiming ing utility in the treatment of nearly 80 specific
either to contain or act on stem cells. Each of conditions, in addition to general efficacy in
these categories in fact represents a diverse col- “cancer, liver and kidney disorders, nervous
lection of products, with heterogeneous, often system disorders, skin disorders, autoimmune
conflicting, theoretical bases and therapeutic disorders, genetic disorders, eye disorders, mus-
aspirations. I will nonetheless seek to provide culoskeletal disorders, fertility and reproductive
an overview of each before highlighting features disorders and cardiovascular disorders” [201] . A
that appear to be common to all. separate Indian clinic boasts of “successfully
treating over 500 diseases” [112] by combining
Human stem cell treatments stem cells with ayurvedic medicine.
Much has already been written about the pheno The opacity and volatility of this industry
menon commonly referred to as ‘stem cell tour- makes it is nearly impossible to gauge its true
ism’ in both the mainstream and scientific extent. A noted Chinese bioethicist stated in
media, as well as in the peer-reviewed literature. 2009 that there were between 100 and 150
Studies of the commercial delivery of unproven stem cell clinics in that country alone [15] , while
stem cell-based treatments have focused on the one report on stem cell clinical activities in
claims made by providers [7] , the global scope of Russia asserted that as many as 500 clinics were
the industry [8,9] , legal, regulatory and ethical engaged in the marketing of unproven stem cell
issues [10,11] , and analysis of patient blogs [12] and treatments [16] . English-language websites have
media accounts [13] . Research societies and dis- also proliferated in recent years, and while no
ease-focused advocacy groups have additionally systematic attempt has been made to enumerate
issued warnings to patients regarding untested them, representative samples have appeared in
and unregulated cell-based products [14,103] . mainstream and scientific publications [7,9,17,18] ,
The intensity of this response seems justi- and the International Society for Stem Cell
fied by the growing number of companies now Research is currently developing a database of
engaged in marketing unproven stem cell treat- stem cell treatment providers based on degrees
ments and patients seeking out their services, of compliance with internationally recognized
as well as the breadth of the therapeutic claims standards of practice and ethical conduct [14] .
made by providers and the increasing sophis- Information on revenue is also scarce, but
tication of their marketing efforts. Providers estimations for some clinics can be made on
of ‘stem cell’ treatments make a broad range self-reported fee structures and patient numbers,
is to depict any restriction on the marketing of of human cells and tissues. China enacted a new
unproven treatments as a curtailment of patient law on advanced medical technologies in 2009,
choice [111,153] . In its most extreme forms, this and the Thai Medical Council passed binding
is framed as a conspiracy in which the medical guidelines on such applications in the same year.
establishment, the pharmaceuticals industry, Germany has revised its rules on the clinical
research societies and government agencies are use of autologous stem cells, with a deadline for
colluding to keep effective treatments out of the seeking approval for such uses of 30 December,
hands of patients in the interests of protecting 2012. In Costa Rica, the Ministry of Health shut
status quo business models [154] . down a prominent stem cell clinic in 2010, while
While they are undoubtedly persuasive, even in Hungary arrests were made over the illegal
compelling, none of these conceptualizations marketing of fetal stem cell injections.
overcome the bare fact that very few stem cell Should stem cell interventions currently being
treatments have been shown to be both safe and tested for safety and efficacy gain regulatory
effective in well-designed and rigorous trials. approval, this will also presumably affect the
Despite their great promise, the true potential of commercialization of unsubstantiated stem cell
stem cells in medicine remains largely unrealized products. Not only will this provide a solid evi-
at present, with the notable exception of hemato dentiary basis on which patients will be able to
poietic stem cells in the treatment of blood and make informed healthcare decisions, it will open
immune disorders. The popularity and profit- up the possibility of having approved treatments
ability of stem cell products in alternative med- reimbursed by insurers. It is uncertain at present
icine speaks more to the power of expectancy which, if any, stem cell-based applications will
and desire than it does to any objective effect in clear these thresholds, but the availability of true
the specific clinical contexts in which they are therapies based on scientific evidence will be a
being delivered. In my opinion it is this power welcome alternative to the baseless offerings of
of persuasion, of manufactured convictions and alternative stem cell medicine at present.
the ‘triumph of hope over experiments’ that
characterizes alternative medicine as a whole. Financial & competing interests disclosure
The author has no relevant affiliations or financial involve-
Future perspective ment with any organization or entity with a financial
Despite the surging expansion and diversity of interest in or financial conflict with the subject matter or
the commercialization of untested and under- materials discussed in the manuscript. This includes
regulated stem cell interventions in recent years, employment, consultancies, honoraria, stock ownership or
there are signs that this growth may abate in options, expert testimony, grants or patents received or
the near- to mid-term. Competent authorities pending, or royalties.
in numerous countries have begun to develop or No writing assistance was utilized in the production of
enforce regulations over the clinical application this manuscript.
Executive summary
The concept of stem cells has been adopted in an aggressive and widespread manner by providers of unproven medical treatments.
Untested interventions claiming to use human stem cells of various types have emerged into a major international industry.
The use of freeze-dried animal cells is also seeing a resurgence, and frequently adopts terminology from stem cell biology to modernize
the conceptual basis of these products.
A number of nutritional supplement products claiming to enhance stem cell counts or function have been introduced, typically via
web-based marketing approaches.
In addition to medical uses, the use of stem cell products and procedures in cosmetics and esthetic surgery is growing.
Alternative stem cell practitioners appeal to concepts such as naturalness, patient identity and choice, and an us versus them mentality,
in promoting their products and claims.
nn of considerable interest 3 Bausell RB: Snake Oil Science: The Truth Alternative Medicine on Trial. Corgi Press,
About Complementary and Alternative London, UK (2009).
1 Angell M, Kassirer P: Alternative
Medicine. Oxford University Press, Oxford, 5 Kligler B, Maizes V, Schachter S et al.:
medicine – the risks of untested and
UK (2007). Core competencies in integrative medicine
unregulated remedies. N. Engl. J. Med. 339,
839–841 (1998). n Comprehensive, book-length examination for medical school curricula: a proposal.
of the weak evidence basis for a wide range Acad. Med. 79(6), 521–531 (2004).
138 Cellport Clinic www.newscientist.com/article/dn17551- 151 Morris J, Coles LS: Will the FDA kill adult
www.cellport.jp/english guerrilla-stem-cell-clinic-raided-by-police. stem cell medicine? H+ Magazine,
139 Thompson A: A barbaric kind of beauty. html 1 May 2009
Daily Mail, 7 August 2006 145 Eggington S: Pair fights US extradition. http://hplusmagazine.com/articles/bio/
www.dailymail.co.uk/femail/ Times Live, 18 July 2010 will-fda-kill-adult-stem-cell-medicine
article-399376/A-barbaric-kind-beauty.html www.timeslive.co.za/local/article557236.ece/ 152 Levine AD: Stem cell Tourism: Assessing the
140 Plastic Surgery Center Internationale Pair-fights-US-extradition State of Knowledge. SCRIPTed 7(2),
www.youthfulneck.com/stem-cell-face-lifts. 146 Novelo A: Medical Council says stem cell 274–282 (2010)
htm surgeon should be arrested. The Reporter, www.law.ed.ac.uk/ahrc/script-ed/vol7–2/
19 October 2007 levine.pdf
141 Dr Calabria
www.drcalabria.com/procedures_face_ www.reporter.bz/index.php?mod=archive&a 153 ICMS Open Letter to Stem Cell Clinics
vertical.asp ct=view&article=2274&highlight=ghen&ma www.cellmedicinesociety.org/physicians/
tch= stem-cells-in-clinics/open-letter
142 American Society for Aesthetic Plastic
Surgery website 147 Cytopeutics 154 Repair Stem cell Institute press release.
www.surgery.org/media/news-releases/ www.cytopeutics.com/Pilot_Programmes. 24 August 2010
major-plastic-surgery-societies-commend-los- html www.prweb.com/releases/stem-cells/
angeles-times’-balanced-reporting-of- 148 Clinika MD Margolis/prweb4401904.htm
controversial-“stem-cell-fa www.clinikamd.com/stem_cell_therapy.html
143 Carroll R: Costa Rican health ministry bans 149 Returning Hope
Patent
experimental stem cell treatment. Guardian www.returninghope.com/diabetes/
page 15, 7 June 2010 diabetes-treatment-process.html 201 Geeta Shroff: WO 2007141657 20071213
www.guardian.co.uk/world/2010/jun/07/ Compositions comprising human embryonic
150 Dr Kraft
costa-rica-stem-cell-treatment stem cells and their derivatives, methods of
http://drkraft.net
use, and methods of preparation.
144 Coghlan A: ‘Guerrila’ stem cell clinic
raided by police. New Scientist, August 2009