Ubaka Ogbogu, LLB, BL, LLM Adjunct Associate Professor of Law Associate Director of Research and Education Consortium on Law and Values in Health, Environment.
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Slide 1
Ubaka Ogbogu, LLB, BL, LLM Adjunct Associate Professor of Law
Associate Director of Research and Education Consortium on Law and
Values in Health, Environment and the Life Sciences & Joint
Degree Program in Law, Health and the Life Sciences University of
Minnesota Beyond evidence and regulation: Medical tourism and the
direct-to-consumer marketing of stem cell therapies
Slide 2
Outline Media reports and examples of stem cell offerings
Research objectives/questions Research methodology Results
Conclusion Current policy landscape
Slide 3
Somatic stem cell research has reached the clinical trial phase
for diabetes mellitus, MS, stroke, myocardial infarction, among
others. Therapies remain unapproved and unavailable outside of
experimental trials due to knowledge gaps, technical challenges,
and regulatory hurdles.* Only one approved hESC therapy clinical
trial, currently on hold due to safety concerns. Stem cell cures:
Ready for prime time?
Slide 4
Putative Stem Cell Therapies and Offerings Our website is
solely dedicated to providing you with up to date and on target
information on stem cells, research and current treatments
available in China If you are interested in getting more
information about finding a treatment in China for a specific
ailment, and you are in North America, you can call us toll
free...
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Research Objectives/Questions Review of media reports indicated
that DTCA via the Internet plays an important role Primary
objective was to document and characterize a novel occurrence of
DTCA What sorts of therapies are offered? How are they portrayed?
Is there clinical/scientific evidence to support the use of these
therapies? Are they regulated and in what way?
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Study methods Two prongs: Content analysis of websites offering
stem cell therapies EBM-based analysis of peer-reviewed clinical
evidence for primary human studies reporting clinical effects of
any stem cell therapies* Websites identified through media reports
and Google searches (final sample:19) and coded for therapeutic
offerings, indications, claims, benefits, risks, cost of therapy,
evidence, location of clinic, etc. Clinical evidence identified
through comprehensive PUBMED search. 45 records met relevance
criteria Inter-coder reliability testing completed on random
sample
Stem cell sources Stem cell sourceFrequency Bone marrow7 Blood
or marrow donors5 Peripheral blood5 Fetuses4 Fat2 Unspecified2
Other (animal sources (shark, sheep) and skin stem cells) 3
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Transplantation procedure ProcedureFrequency Intrathecal, into
CSF6 Intravenous6 Subcutaneous or intramuscular4 Surgical
transplantation4 Catheterization of deep body vessels (injection
deep into the brain via craniotomy or by injection into the spinal
cord parenchyma via laminectomy) 3 By mouth1 Topical1
Benefits vs. Risks Mentioned All websites surveyed mentioned
improvement of disease state as main benefit of treatment 14 (74%)
of the websites did not mention any risks Few websites mentioned
procedural risks, and nonspecific fever and tingling as only risks
of procedure
Slide 13
Example statements Of over 1800 patients we have treated, we
estimate that 85% have gotten some kind of improvement and 80% have
been satisfied with the improvements that they have gotten. We by
no means guarantee improvement, but... we are extremely surprised
when patients do not get improvement Transplantation is a safe,
painless procedure. It is conducted in a sterile environment by
professional medical personnel List of contraindications against
cell therapy is rather limited. No negative side effects were
observed
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Treatment portrayals Indications scored very or somewhat
unclear or indeterminate in 68% of sites (websites use catch-all
categories like aging, increased feelings of energy) 12 of 19
websites has indications which spanned 4 or more broad disease
categories Benefits portrayed as somewhat or very relevant in 79%
of websites Risks portrayed as very irrelevant in 74% of websites
17 of 19 websites portrayed treatments as routine or somewhat
routine Credibility established through numerous patient
endorsements, patent claims, media reports, and publications
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We have proved that the efficacy of autologous stem cell
therapy in minor spinal cord injury ranges from 45 to 70%. Here
everything depends on the size of the lesion, the level of injury,
and the years post injury. The best results were obtained in the
patients with thoracic level of injury; 2-5 years post injury and
incompleteness of SCI Neurovita.ru
Slide 16
Location Number of clinics Mexico4 China3 India, Philippines,
Russia, Thailand2 Puerto Rico, Holland, Ukraine, Costa Rica,
Barbados, Dominican Republic, Turkey, Germany 1
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Clinical evidence study: Inclusion/exclusion criteria Targeted
indications mentioned 10 or more times in top 2 disease categories:
neurologic & cardiovascular MS, Parkinsons disease, Stroke,
Alzheimers disease, SCI, and autologous hematopoietic stem cell
transplantation (AHSCT) for acute myocardial infarction (AMI) 89
total records, of which 45 included. Excluded records were
unavailable (1), duplicative, non-stem cell interventions, reviews,
or non-English (2), or referenced no clinical outcomes Study not
focused on describing current state of stem cell medicine
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Results Evidence for stem cell therapies for SCI and stroke is
generally underdeveloped: small size, low methodological quality
(e.g., no control group), and uncertain, negative, or contradictory
findings No studies of stem cell therapy for Alzheimers or
Parkinsons Some history of stem cell therapy for MS, but clinical
outcomes are variable and not obviously better than the natural
history of patients with multiple sclerosis Treatment
recommendations made on the basis of the reviewed evidence likely
to be low grade Treatments offered by websites generally
unsupported by clinical evidence
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Study Limitations Publicly available information is not
indicative of information actually shared with patients during
clinical encounters We did not analyze actual outcome data for
particular clinics. Instead we showed that high quality supporting
evidence is lacking Bias from exclusion of non-English studies.
However only 2 such studies were excluded
Slide 20
Conclusions DTC portrayal of current stem cell medicine appears
optimistic and unsupported by clinical evidence Patients may not be
receiving proper or accurate information, and are subject to
inordinate risk and financial burden Clinics may be contributing to
stem cell hype Tourism aspect complicates post-treatment
monitoring, protection of patient rights and regulatory
scrutiny
Slide 21
Current policy landscape Supranational soft regulation and
advocacy (ISSCR, JDRF Intl, ALS Worldwide) Statutory intervention
through physician standard of care rules? Physicians duty to report
abuse, neglect, or situations of risk under minor and incompetent
adult welfare legislation Truth in advertising rules (FTC) Local
regulation stem cell clinics have been shut down by regulators in
the Netherlands, Ireland, US Lobbying by research community for
stricter national regulation
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Acknowledgments Co-authors: Darren Lau, Timothy Caulfield,
Tania Stafinski, Devidas Menon, Benjamin Taylor Canadian Stem Cell
Network REMEDiE Linda Hogle