Cell therapy is
therapy in which cellular material is injected into a patient1. Nowadays,
various cell therapies are approved and used clinically. And many products are
currently under active investigation worldwide and their market size is
expected to grow rapidly in the near future. Ministry of Food and Drug Safety
mentioned the global trend of stem cell therapy product in August 28, 2013 and
said that market size will grow to 6.6 billion dollars in 2016 from 3.5 billion
dollars last year. Global markets for stem cells by BCC Research (2012), cited
by Ministry of Food and Drug Safety, predicted the global market size of stem
cell therapy product would be 6.6 billion dollars in 2016 and grow 11.7% on
average every year. Currently, US’s stem cell therapy product occupying the
biggest market share amounts to 1.3 billion dollars and Europe’s is 872 million
dollars. US’s stem cell therapy product market is predicted to have an average
annual growth rate of 11.5% (2.3 billion dollars in 2016), and Europe’s is
10.9% (1.5 billion dollars in 2016). Until August 1, 2013, three stem cell
therapies has acquired a sale permit for domestic use in Korea:
Hearticellgram-AMI by FCB-Phamicell (the world’s first stem cell therapy
product), Cartistem by Medipost (the world’s first allogenous stem cell therapy
product) and Cupistem by Anterogen. Besides, 24 medicines are undergoing
clinical trial till January 1, 2013. The cell therapy product treatment is
different from the existing one because it is personalized, and this is
valuable progress for the personalized medicine. Most of the medicine, up to
now, is organic compounds or proteins to alleviate the symptom, not for
ultimate cure. However, cell therapy product can be said to be the beginning of
new technology confronting disease, because it is pursuing ultimate cure of
disease. Cell therapy product uses cell itself as medicine, which mostly were
made from patient’s own tissue to have certain properties by manipulation and
culture, and injected back to the patient. Therefore, cell therapy product is
called personalized medicine compared to the medicine with mass production for
all. Today two distinct categories of cell therapy are reco-gnized1. The first
category is cell therapy in mainstream medicine. Allogenic cell therapy, human
embryonic stem cell therapy, neural stem cell therapy, mesenchymal stem cell
therapy and hematopoietic stem cell therapy belong to this category. This is
the subject of intense research and the basis of potential therapeutic
benefit2. Such research, especially when it involves human embryonic material,
is controversial. The second category is in alternative medicine, and
perpetuates the practice of injecting animal materials in an attempt to cure
disease. This practice, according to the American Cancer Society, is not backed
by any medical evidence of effectiveness, and can have deadly consequences1.
The cell therapy technologies are already started to play an important role in
the practice of medicine and cell therapy is bound to become a part of medical
practice. Cell therapy technologies overlap with those of gene therapy, cancer
vaccines, drug delivery, tissue engineering and regenerative medicine. Methods
of delivery of cell therapy product range from injections to surgical
implantation using special devices. Cell therapy has applications in a large
number of disorders. The most important are diseases of the nervous system and
cancer. Other applications include cardiac disorders (myocardial infarction and
heart failure), diabetes mellitus, diseases of bones and joints, genetic disorders,
and wounds of the skin and soft tissues3. Cell therapy product, suggesting a
new paradigm of medicine, is technically very important and also very
mea-ningful as country’s growth engine in post-IT era. Korean government
invested 100 billion won for research and development (R&D) in 2012.
Ministry of Health and Welfare launched Global Stem Cell and Regenerative
Medicine Initiative and invested 45 billion won for R&D (15 billion won in
2011: Ministry of Education and Science Technology invested 40 billion won in
2011 and 49 billion won in 2012), and it intensely supports transitional
clinical research in the field of Stem Cell and Regenerative Medicine. Besides,
Ministry of Health and Welfare leads an active examination over the law and
system about Stem Cell and Regenerative Medicine4. There are so many problems
to solve; the lack of guideline for the cell therapy product specialized
clinical research procedure, establishing the effectiveness of treatment,
treating side effects and so on, but cell therapy product for treating human
disease is an inevitable process for biotechnology. Especially, when we try to
understand more about development and differentiation through the study of stem
cell as well as the biotechnology development like implementing Human Genome
Project and apply to the patients by investigating the mechanism of disease,
cell therapy product could suggest new revolutionary treating method which is
totally different from the existing one. Nowadays, the developed countries’
government and corporation are concentrating on R&D and commercializing of
cell therapy product. This means that cell therapy product has high potential
and enough effective value in the market. It could be the beginning of new age
for the new technology to realize the personalized medicine. There are many
obstacles to get over: regulation, safety and ethical issue and so on. However,
we, oral and maxillofacial surgeons try to take a continuous interest in,
research and cooperate to the development of cell therapy and cell therapy
product.