Bridging
the gap between bench and bedside, stem cell research is showing promising results
in clinical trials worldwide.
There is only one set of
circumstances where man puts his effort, energy, time and
money to get the less specialized, the less differentiated, the less evolved.
And that is Stem Cell Research. Stem cells are the unspecialized cells with the
potential to divide continuously to self-replenish and under certain
circumstances can differentiate into specialized cells of characteristic
phenotype and function. During embryonic stage and early periods of growth, embryonic stem
cells divide and differentiate to form the entire body of the organism with
all its extremely intricate organ systems. Whereas in the adult organism, somatic stem
cells maintain an internal repair mechanism by constantly replenishing and
replacing aging cells. Scientific research is gearing towards utilizing stem
cells as an elixir for degenerative and autoimmune diseases. Under controlled
conditions in laboratory, genetic reprogramming can generate pluripotency in
differentiated cells (induced pluripotent cells; iPSCs) which have
extensive medical and commercial prospects in drug therapeutics and stem cell
therapeutics.
In the February of 2015, a stem
cell based therapeutic product was approved for commercial marketing for the
first time in the world as The European Medicines Agency approved Holocar for the treatment of
blindness caused by limbal stem cell deficiency post physical or chemical
burns. Boasting a struggle of 25 long years to bring this product from bench to
bedside, researchers, industrialists and clinicians behind
the scenes have opened a wide arena
of therapy and hope to common man. The International Society for Stem Cell
research (ISSCR) consolidates stem cell
research around the globe through updated publications, funding resources,
annual meetings, international symposiums and the ‘Guidelines
for Stem Cell science and Clinical Translation’. Clinical trials using bone
marrow, umbilical cord blood, placental and mesenchymal stem cells for cardiac
repair, neurodegenerative diseases, hematological disorders and autoimmune
diseases is showing promising results worldwide. Stem Cell Technologies have an online tool for
finding the stem cell clinical trials going on in hospitals for various
diseases which will help patients to access the facilities under strict regulations.
This is adapted from the clinical trial registry
maintained by National Institutes of Health (NIH).
Growing at a rate of 30%
per annum, the stem cell industry is expected to hit a turnover of $1.2 billion
by 2017 worldwide. Forbes
reports that the Indian industry is estimated to hold a significant proportion
of this market with a worth of $600 million by then. Basic and translational
research in this field is funded by funds worth more than three hundred crore
rupees mobilized by Department
of Biotechnology (DBT) and Indian Council for Medical Research (ICMR) over
the past seven years under the supervision of dedicated Task Force teams. But
as the research in this field is still crawling in its bassinet, the use of
stem cells for therapy in patients may pose grave risks with our relative
ignorance about adverse effects. Stem cells, with their immense potential to
divide and differentiate in the body, require close monitoring and extremely
tight management conditions to be used in patients in a hospital set up. To
curb the chances of malpractice in the field, ICMR Department of Health Research
and DBT have revised and published the ‘National Guidelines for
Stem Cell Research’ in 2013. These guidelines encourage stem cell research
at basic and applied levels with adequate regulations but strictly prohibit
stem cells for therapy other than the hematopoietic stem cells transplantation
(HSCT) for hematological disorders in India. The National Apex Committee for
Stem Cell Research and Therapy (NAC-SCRT) monitors the
regulatory approvals for clinical trials involving stem cells. Numerous
companies in private sector like Lifecell, Stemade
(India) and Bioeden (U.S.) offer cord stem cell storage facilities in
India at affordable costs today. Let us hope that the new generation, with the
privilege of its own stored stem cells, gets the opportunity to address and
contain diseases with the commendable progress in stem cell research.
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