International Stem Cell Corp., a developer of ethical stem
cell therapies (as well as biomedical products) based on their pioneering of an
entirely new class of stem cells, hpSCs, or human parthenogenetic stem cells,
which offer significant advantages over existing stem cell technologies,
continues to see the broad spectrum potential of their technology across the
company’s entire therapeutic pipeline.
Parthenogenesis is a form of aesexual reproductive cell
division where no fertilization occurs, meaning that no viable embryo is
created or destroyed. Derived from unfertilized human eggs (oocytes) and
differentiated using a proprietary, patented and chemically-defined process,
ISCO’s hpSCs are completely ethical and yet also have superior immune matching
(low cell transplant rejection rate) and histocompatability (tissue
compatibility) properties compared to existing stem cell technologies. In
addition, hpSCs are highly pluripotent, or differentiable into many different
cell types, meaning they can be used to treat a broad range of diseases. These
novel stem cells are also easily proliferated, meaning large quantities can be
grown in the lab and the technology thusly represent an effective, practical
solution for developing and executing cost-effective transplantation-based
therapies, even for large populations of patients.
Indeed, the fact that ISCO’s hpSC technology allows for
derivation of HLA (human leukocyte antigen, the major histocompatibility
complex which restricts antigen presentation) homozygous hpSCs, even a
relatively limited set of hpSC lines could be used to generate huge quantities
of immune-matched cells that would correspond to vast swathes of the human
population. This innovative technology captures all the best aspects of other
extant stem cell technologies, like adult stem cells, embryonic stem cells
(hESC) and induced pluripotent stem cells (iPS), but does not suffer from any
of the ethical or logistical limitations. This means that ISCO is essentially
the tip of the spear in a therapeutically realistic war against dreaded
diseases like Parkinson’s, with real solutions in the offing for ischemic
(acute) stroke, as well as metabolic liver diseases (using stem cell-derived
liver cells – CytoHep), and the crippling impairment of corneal and retinal
blindness (using human retinal epithelium and corneal cells – RPE cells and
CytoCor respectively).
With FDA clearance for the company’s hpSC technology already
under their belt, as well as a soon to begin Phase 1/2a clinical study in
Parkinson’s using their human parthenogenetic neural stem cell technology
(ISC-hpNSC), including the already completed production of a 2.6 billion cell
stem cell bank that will cover all clinical trial requirements, ISCO is within
striking distance of having a viable therapeutic solution to Parkinson’s
disease. ISCO’s progress in developing a therapeutically realistic solution to
this increasingly prevalent CNS disease no doubt appears as a beacon of hope on
the horizon to the millions of people around the world whose lives have been
shattered by this disease, which currently impacts the lives of as many as
seven million people and takes a heavy toll on their families (not to mention
national healthcare systems), due to a progressive loss of nerve cells in the
victim’s brain that leads to severe motor and mental impairment.
According to one National Parkinson Foundation study, as
many as 9.3 million people worldwide will be living with Parkinson’s disease
(PD) by 2030 and estimates for the U.S. alone show that as many as 60,000 new
cases crop up each year. Market analysis from last year put the (note that
these are typically only marginally effective) 2012 PD therapy market at around
$3.56 billion globally ($1.15 billion U.S.) with only 2.18 million cases
reported. Conservative estimates forecast that the diagnostics/therapy market
will grow to $5.26 billion worldwide ($2.33 billion U.S.) within the next seven
years alone, using extrapolated market size estimates on a target of only 2.89
million cases.
The profound utility of ISCO’s ISC-hpNSC technology doesn’t
stop at PD either, the same ability of these cells to simultaneously
differentiate into dopaminergic neurons, while also expressing brain-protecting
neurotrophic factors (neurotrophins are key proteins which help neurons survive
and thrive), makes them ideal for treating other CNS disorders and diseases.
New results which show ISC-hpNSCs may not only reduce but even reverse the
symptoms of neurological dysfunction could prove huge for people who have
suffered from a stroke, especially considering that the 795,000 plus strokes
which occur each year leave those who manage to survive with zero currently
approved treatment options, aside from grueling and generally only partially
effective physical rehab.
Peer-reviewed publications showing the superior
immunological properties of hpNSCs compared to other neural stem cells is also
an extremely promising advantage for ISCO and the company has plans to
investigate this abundant potential in further detail via upcoming studies. A
presentation of extant data on the potential of hpNSCs, including how they are
actually attracted to the site of an injury by naturally-occurring molecular
chemistry signals, reducing swelling and forming new brain tissue, is set to
take place at an upcoming scientific conference and will be announced in the
very near future. For ischemic stroke (which accounts for nearly 90% of all
stroke cases), the $1.2 billion diagnosis and therapy market as of 2013 set to
hit $1.9 billion in five years (6.3% CAGR), where the immediacy of therapeutic
response time is directly proportional to recovery outcomes (success), the
value of hpNSC therapy, which has been shown in pre-clinical work to reverse
associated functional deficits even several weeks after the stroke, is
substantial.
A highly effective therapy for acute stroke that can be
applied even weeks after the actual stroke would be a major game changer and
could help propel ISCO to the top of the stem cell industry.
Dig deeper into this innovative stem cell therapy developer
at www.internationalstemcell.com
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