Biotechs face stronger regulation of stem cell treatment
Health & Biotech
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Stem cell therapy is an exciting area of medicine.
There’s something futuristic about using your own cells to heal yourself.
Research on stem cell therapy has revealed many treatment applications, and every year we find another.
Australians have had to travel overseas to receive stem cell therapies for chronic pain, nerve damage, wound treatment, even diabetes and neurodegenerative treatments.
These treatments (and clinics) haven’t always been the safest or even evidence-based, but were offered to desperate patients looking for a solution.
In recent years, Australia has been a leader in stem cell therapy applications through research undertaken in private companies and public institutions backed by a generous 43.5 per cent federal government R&D tax incentive to get innovation bubbling away in our great nation.
Victoria alone is a powerhouse for the biotech sector, employing more than 20,000 people across 150 biotech companies, 10 major medical research institutes, 10 teaching hospitals and nine universities across Victoria – generating in excess of $10 billion annually.
Dr Melanie Thomson, GM of Education, Skills and Events at MTPConnect, says they have been working with the sector to identify significant areas in which Australian researchers and developers have competitive advantage relative to our global peers, of which regenerative medicine was identified.
ASX-listed stem cell therapy companies include Mesoblast (ASX:MSB), Cynata Therapeutics (ASX:CYP), Regeneus (ASX: RGS), Calimmune (acquired by CSL Behring for $91 million in August this year), Orthocell (ASX:OCC), Avita Medical (ASX:AVH), and that’s just naming those making major strategic moves in 2017.
A recent Orthocell press release boasted of the potential market value for orthopaedic soft tissue repair to reach more than $US10 billion by 2020.
In 2015 US-based biotech giant Celgene Corporation invested $58.5 million to buy about 4.7% of Mesoblast, resulting in a 22% raise in shares for Mesoblast.
However there is a lot of controversy surrounding stem cell therapy in Australian biotech circles.
While a vital part of proving efficacy includes treating patients in clinics for the purpose of controlled trials and is highly regulated by the Therapeutic Goods Authority (TGA), however some companies have seen an opportunity to cash in.
A loophole in the TGA guidelines allows patients to be treated with their own cells (autologous cells), and although this area is still unproven and highly risky, private clinics have been offering autologous therapy direct to patient as an alternative to current treatments for conditions including rare blood diseases, osteoarthritis and even for cosmetic purposes, with very little information on risks and realistic outcomes.
“Speaking also as a patient with a degenerative condition who may benefit from such innovative therapies, I am cautiously optimistic about the future outcomes of this technology for health,” Dr Thomson said.
“My experience as a patient, and as an academic and executive within the sector, means that I understand the vital importance of making information on evidence based developments in this field accessible to the general public – such as that provided by Stem Cells Australia – to ensure that patients are receiving treatment that has the highest likelihood of positively impacting their lives.’’
Professor Melissa Little from research group Stem Cells Australia at the University of Melbourne says her organisation has been engaging with the professional medical bodies, particularly orthopaedics, and looking to develop a system of stem cell counsellors to provide more accurate advice to patients seeking stem cell treatments.
The Australian Commercialisation Centre for the Regenerative Medicine (CCRM) is being established through an MTPConnect Project Fund Program.
CCRM Australia will be modelled on, and linked with, the highly successful CCRM based in Canada.
Dr Thomson says MTPConnect “continues to work with TGA on streamlining and harmonising regulation in this space’’.
Professor of health, law and ethics at the University of Sydney, Prof Cameron Stewart is concerned about the marketing of the treatments.
There are significant legal and ethical risks facing the medical industry, and stem cell therapy is an indication of this problem, he says.
“Patients have been sold this idea that if a treatment is innovative or experimental, then it’s good – but that’s not necessarily true. These treatments are very expensive for the patient and they may not understand that it is unproven.’
“Also we see in the US the argument of the ‘right to try’, where medical care is being driven by consumer demand.
“What we are actually seeing is the product of misinformation, with misleading conduct from clinicians towards desperate patients who are uninformed of the side effects.”
Prof Stewart wants to see the sector, currently regulated as a product under the TGA, to include the Australian Health Practitioner Regulation Agency (AHPRA) as the therapies become available in clinics, thus forcing the onus of responsibility onto the treating health practitioner.
Professor Stewart will be speaking on this topic at Queensland University of Technology’s Health Ethics and Law research group on Tuesday 10 October. This event is open to the public, please visit this link to attend.