Growth in clinical trials involving novel stem cells
Modified from Li et al. Regen Med 2014
‘Stem cell’ interventions Cosmecueticals Alternative medicines Animal products Standard care & Approved products
Clinical research Nutraceuticals
Modified: Sipp et al., 2015 (submitted)
The business of selling stem cells Alternative therapies Standard care & Approved products
Clinical research
Commercial stem cell clinics & companies
The business of selling stem cells Ø Not recognised treatment - offered outside clinical trials Ø Marketed direct to consumer - testimonials & internet
Ø ‘Magic bullet’ - one approach, many conditions
Ø Safe + show ‘improvement’ - limited credible evidence Ø Non-expert doctors Ø Expensive & highly invasive Ø Diverts from existing care
Commercial stem cell clinics & companies
The business of selling stem cells Alternative medicines Standard care & Approved products
Clinical research
Commercial stem cell clinics & companies
The business of selling stem cells
Connolly et al (2014) Travel Med Infect Dis SEARCH: stem cell clinic, stem cell cure, stem cell therapy, stem cell treatment, stem cell centre
68 stem cell clinics
The business of selling stem cells 2014: 43 practitioners in 14 clinics Ø Autologous – fat or blood
Musculoskeletal
Musculoskeletal + diverse chronic diseases and illnesses* Musculoskeletal + rejuvenative Diverse chronic disease and illnesses* Rejuvenative Autism
Munsie & Pera (2014) Stem Cells Dev
Connolly et al (2014) Travel Med Infect Dis SEARCH: stem cell clinic, stem cell cure, stem cell therapy, stem cell treatment, stem cell centre
68 stem cell clinics
The business of selling stem cells
IV infusion Nebuliser Lumbar puncture
Connolly et al (2014) Travel Med Infect Dis SEARCH: stem cell clinic, stem cell cure, stem cell therapy, stem cell treatment, stem cell centre
68 stem cell clinics
2011 Framework for ‘biologicals’ Need: • Minimise risk of infectious disease transmission • Support greater international harmonisation • Level of regulation to match level of risk/ manipulation Ø Broad exclusion around all autologous cell therapies no matter degree of manipulation nor whether homologous use or not CLASS / RISK
CONSIDERATION
EXAMPLE
2 – Low
- Minimal manipulation & homologous use
Allografts - milled bone Heart valves & corneas
3 – Medium
- More than minimal manipulation but does not change inherent properties
- Processed in a way that changes inherent properties
Genetically modified fibroblasts for repair in muscular dystrophy
Prof Alan Petersen
Dr Claire Tanner
Ms Jane Brophy
Dr Casimir MacGregor
Creating a market for hope at home:
Unproven ‘stem cell’ treatments in Australia •
Views of Australian providers of autologous interventions n=6 (mainly using lipoaspirate)
•
Huge unmet need/demand ‘People I see are ... completely fed up with… the system…Some have been overseas and it doesn’t work and they’re looking for something else’
•
Feel justified in providing treatment but concerned about others ‘They come to me for a second opinion….they don’t have confidence in this other group. They feel the other group is all about money and not about science or research’
•
Support for greater oversight ‘I do have faith that, that the practitioners can self-regulate, so long as they can get together and formulate a series of protocols. But then you need some, some legislative authority to be able to enforce them. .’
•
Australia as a destination of choice to establish new industry ‘So I know of multinational companies that view Australia as a base for bringing stem cell tourists from [Asia] …. And the Australian, the stable Australian economy and political situation, is better than Syria and Romania… . ‘
Option 1: Continue to exclude autologous cells from regulation under the Act#
Option 2: Exclude autologous stem cells from regulation under the Act in defined circumstances
Option 3: Regulate autologous stem cells under Act, but exempt from registration and manufacturing requirements
Option 4: Regulate under the Act as Class 1 biologicals
Option 5: Regulate under the Act as Class 2, 3 or 4 biologicals
Advertising restrictions
No (still subject to ACCC and AHPRA)
Yes
Yes
Yes
Yes
TG Act standards
No
No
Yes
Yes
Yes
Adverse effect No reporting
No
Yes
Yes
Yes
Safety requirements
No
No
No
Yes
Yes
Efficacy No requirements
No
No
No
Yes
Manufacturing No
No
No
No
Yes
# Exclude under s 7AA of Act all ‘stem cells’ currently covered by 4(q) of the Excluded Goods Order
Innovative medicine? “It is a fallacy to suggest that clinical trials discover new treatments. New treatments are discovered in the process of medical innova:on.”
Submission to TGA by Australian doctor providing autologous interven8ons
Lindvall and Hyun 2009 Science 324:1664-5
Medical board raises concerns about cosmetic medical and surgical procedures Ø Shared by Australian ‘stem cell’ doctors ² Interventions are elective
- usually initiated & requested by patients
² Interventions are performed outside the public health system - in private hospitals, day procedure centres and medical practitioners’ rooms
² Some prospective patients may be vulnerable to exploitation when making decisions about purchasing interventions ² Interventions usually paid for directly by the consumer
- can be of considerable cost which may not be eligible for Medicare or private health insurers
² Little is known about the number of medical practitioners providing these interventions as it is not recognised as a speciality
