Standardized research guidelines are needed
to control and encourage the development of gene therapy and stem cell
treatments, according to a new report by healthcare experts GBI Research.
The new
report shows how regenerative medicine is seen as an area with high future
potential, as countries need ways to cope with the burden of an aging
population.
The
stem cell market alone is predicted to grow to around $5.1 billion by 2014,
while gene therapy has also shown promise despite poor understanding of some
areas of regenerative medicine and a lack of major approvals (the only
approvals to date being made in Asia).
Up
until now, securing research within clinics has been difficult, with a high
number of failures and discontinuations throughout all phases of clinical
study. Stem cell therapy uses bone marrow transplants as an established
treatment method, but the development of the therapy into further applications
and has not yet become common practice.
Similarly,
tissue engineering has been successful in the areas of skin and bone grafts,
but translation into more complex therapies has been an issue for researchers.
Although scientific possibilities are ever-increasing, the true potential of
regenerative medicine has yet to be demonstrated fully.
A
desire to discover new and innovative technologies has encouraged governments
in the UK and Singapore to focus directly on regenerative medicine as a future
potential economy booster. They have provided funding and incentives for
companies to conduct their research in the country, along with the creation of
hubs of knowledge and permissive regulatory environments to encourage research.
Funding for industry and research groups is a vital part of furthering
regenerative medicine, especially in taking therapies through clinical trials
and on to commercialization. As more regions find a desire to attract industry
and expertise, more focus is likely to be given to regenerative medicine.
However,
uncertainties over legislation and funding from government bodies, especially
in regard to ethically controversial therapies such as human embryonic stem
cell research, are still deterring investors. President Obama overturned a
ruling on a ban on NIH (US National Institutes of Health) funding for human
embryonic stem cell research, but a newly elected party may scrap this valuable
route of funding.
Regulatory
pathways for the new and emerging field of regenerative medicine can be
problematic for companies looking to enter markets internationally, as
requirements for clinical trial design, required endpoints and approval
legislation are still developing and often differ between countries.
Organizations
such as the International Society for Stem Cell Research (ISSCR) publish
recommended guidelines on working with stem cells, but these are not binding.
Governments must therefore come together to determine a standardized framework
for innovative medical research, in order that positive results and long-term
follow-up data can be produced to solidify the reputation and investment
potential of the regenerative medicine market.
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