Degenerative disorders, which often strike our increasingly
elderly populations, like the roughly 10k baby boomers here in the U.S. hitting
their 60’s and retiring each day, are on the rise all over the planet,
affecting more than 45 million people worldwide. Characterized by nerve cells
progressively deteriorating to the point of cell death, a process which leads
to a host of maladies ranging from Alzheimer’s and Parkinson’s disease, to ALS
(amyotrophic lateral sclerosis) and Huntington’s disease, to name but a few of
the big ones, degenerative disorders currently have few if any real medical
solutions available for patients.
In China, Europe and Japan, the same population and disease
phenomena is occurring. Populations where people are living longer and where
increased environmental exposure to various bio-accumulating toxins is causing
a continued rise in the volume of a variety of neurological diseases and
disorders, for which modern medicine remains largely incapable of providing
substantial cures, and in some cases, even palliative treatments. This is why
the regenerative medicine technology, based on an entirely new class of
ethically manufactured stem cells, which is being aggressively developed
towards full commercialization by International Stem Cell Corporation (OTC:
ISCO), is so exciting.
Parthenogenesis is not a term most people today are familiar
with, but the times they are a-changin’ – and they are changing fast.
Degenerative disorders once thought incurable are now within striking distance
of being effectively combated through the injection of human parthenogenetic
neural stem cells (hpNSCs), which not only have all the best characteristics of
other types of stem cell technologies, but lack their drawbacks as well. Thanks
to the revolutionary work being done by ISCO with pluripotent stem cells (which
that have the ability to mature into several different types of cells), chemically
stimulating oocytes through a process where no embryo is ever created or
destroyed, the dawn of ethical, high-volume, commercial stem cell technology
that could be used to treat a wide variety of diseases, is at hand.
Derived from unfertilized human oocytes, the company’s stem
cell lines can be made, via their proprietary process, into HLA (human
leukocyte antigen) heterozygous “matched” and therefore histocompatible cells
that won’t be rejected by the donor, giving this technology a serious advantage
in a field still plagued by donor cell rejection. HLA homozygous hpSCs can also
be produced which have been shown to exhibit histocompatibility across massive
segments of the global human population, meaning that ISCO’s stem cell bank
approach to the space could put the company at the forefront of supplying
much-needed, large supplies of compatible donor cells to global markets, just
as commercialization of this revolutionary technology dawns worldwide.
The upper limit on therapies involving stem cells is quite
extraordinary, as these cells function like an atomized organ or other tissue
transplant, repairing existing tissue systems by developing into healthy new
cells that replace the damaged ones. In degenerative neurological disorders,
this is truly a quantum leap, as no effective means exists to otherwise replace
brain and other CNS tissue. The idea of injecting Parkinson’s disease (PD)
patients with cultured neural stem cells (hpNSCs) that actually grow into new
brain cells is extraordinary, and this same approach can be used to treat other
neurological diseases as well, for many of which modern medical science can
offer essentially only palliative care.
The current standard of care in PD is with dopamine agonists
and drugs like oral levodopa (L-dopa), which has significant dosing issues that
often lead to episodes where the symptoms of PD reemerge with a vengeance,
particularly in patients who have been on an L-dopa regimen for over five years
or more. In fact, 90 percent of young-onset sufferers treated for more than
five years with L-dopa experience such episodes. L-dopa, while exhibiting fewer
than other antiparkinsonian agents, has numerous adverse effects, including
psychiatric ones, as well as the potential for the patient to develop dopamine
dysregulation syndrome, and even eventual drug resistance. Needless to say,
existing approaches are by no means effective solutions and the advent of an
actual therapy for restoring the underlying tissue systems would be a paradigm
shift of unprecedented magnitude. A shift whose shockwaves would likely
propagate into multiple other degenerative disorders, especially considering
the removal of ethical considerations about where the stem cells come from,
given ISCO’s parthenogenesis production techniques.
The company’s hpNSCs help to repair the brain in several key
ways, like responding to damaged cell signals and releasing anti-inflammatory
molecules that help speed the recovery process. Directly addressing inflammation,
which is one of the major concomitant symptomatological factors in PD, as well
as forming new tissue by developing into new cells, are powerful properties
that could rocket hpNSCs to the front of the line in PD therapy. Being able to
give someone their life back through the application of this technology could
change the way we think about degenerative disorders forever. The idea that we
could take cases where a loved one has become effectively disabled –
representing not just a serious loss for the individual and economy, but
typically creating a significant burden for their families and the healthcare
system – and actually restore them to nearly 100 percent functionality,
represents one of the most exciting frontiers in biomedicine today.
ISCO’s sizeable preclinical GLP and non-GLP study data on
hpNSCs, including brain transplant safety studies conducted in healthy and
induced Parkinson’s disease animals, showed that not only were the hpNSC
injections well-tolerated, with no sign of tumor or other abnormal growth
formation at even high dosages, but that a distinct improvement to motor
function resulted. These same studies further showed the neuroprotectant and
recovery assistance functionality of hpNSCs, as well as a significant increase
in dopamine levels, the primary agent which allows brain cells involved in
movement to communicate with one another. National Parkinson Foundation data
indicates that even in the roughly 15 percent of patients who develop
young-onset Parkinson’s disease before the age of 50, the same loss of some 80
percent of dopamine-producing cells is observed before motor function
impairment arises, something which clearly indicates the potential of ISCO’s
technology.
ISCO is barreling towards their 1/2a clinical study in Parkinson’s
disease over in Australia, which should kick off within the coming handful of
months, as the company has already submitted the requisite CTX (Clinical Trial
Exemption) application needed to commence this landmark study. The high safety
levels of this technology and emerging knowledge of the causes and
symptomatology of degenerative disorders, could even lead to developing hpSCs
into frontline preventative treatments in patients who are identified as at
risk or in the early stages of a given disease.
At any rate, ISCO has their eye on the prize and has already
completed manufacturing a large supply of over 2.6 million clinical-grade
hpNSCs for the Australia Parkinson’s study, enough to easily handle any
foreseeable trial requirements, and further validating their UniStemCell bank
approach to the market. Paired up with their proprietary parthenogenesis
process for manufacturing cells, a regionalized stem cell bank franchising
architecture could be a significant source of future revenues for the company,
serving scientists and populations across the country and around the world with
an essential stem cell line banking framework. Such a framework, while helping
to further validate a growing library of hpSC lines with many people working on
and developing them, could also develop into a serious royalty-generating
engine fueled by diverse, emergent cellular therapeutics.
ISCO has a strong IP position with numerous patents and
filings under their belt too, spanning everything from specific pluripotent
hpSC lines and production methods, to cell differentiation and research
methods, as well as therapeutic and commercial uses. Like the 16 issued and 91
pending patent applications across 15 different patent families, as well as 8
patents pending across 4 different families, covering their stem cell-based
Lifeline Skin Care (http://www.lifelineskincare.com/) products.
For more information, please visit
www.internationalstemcell.com
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