Currently available Parkinson’s disease treatments, while
capable of improving the early symptoms of the disease, lose their effect as
the disease progresses and produce involuntary writing movements in the
patients. As of yet there is no cure for the disease, which is the second most
common neurodegenerative disease and affects over 7 million people worldwide.
International Stem Cell Corp. (OTC: ISCO), a leader in using pluripotent stem
cells in regenerative medicine, this morning issued news regarding its stem
cell technology – signaling a potential blockbuster shift it the treatment of
Parkinson’s disease.
ISCO today announces that its wholly owned subsidiary, Cyto
Therapeutics, has received regulatory approval by the Therapeutics Goods
Administration (TGA) of Australia to initiate a phase I/IIa clinical trial,
dose escalation trial of human parthenogenetic stem cells-derived neural stem
cells (ISC-hpNSC) in patients with moderate to severe Parkinson’s disease.
“We are very pleased to start the first human study of
ISC-hpNSC’s for the treatment of this debilitating disease. There is a large
unmet medical need for new treatments that may halt or reverse the progression
of Parkinson’s disease and we believe our human neural stem cells may fill this
need for the millions of people with this disease” stated Andrey Semechkin,
PhD, ISCO’s chief executive officer. “We look forward to reporting on the
progress of the clinical trial over the coming months.”
ISCO last year announced positive results from its preclinical
studies for its ISC-hpNSC therapeutic candidate. In those preclinical studies,
the cells demonstrated an improvement in Parkinson’s disease symptoms and
increase in brain dopamine levels following the intracranial administration of
ISC-hpNSC. The studies further noted that the ISC-hpNSCs provided neurotrophic
support and cell replacement to dying dopaminergic neurons.
About the clinical study
The upcoming phase I/IIa clinical study – which will be
performed at Royal Melbourne Hospital in Melbourne, Australia – is a dose
escalation safety and preliminary efficacy study of human parthenogenetic stem
cells-derived neural stem cells (ISC-hpNSC) intracranially transplanted into
patients with moderate to severe Parkinson’s disease. The open-label, single center,
uncontrolled clinical trial will evaluate three different dose regimens of 30
million-70 million neural cells. A total of 12 participants with moderate to
severe Parkinson’s disease will be treated. Following transplantation, the
patients will be monitored for 12 months at specified intervals, to evaluate
the safety and biologic activity of ISC-hpNSC.
“We are the first company in the world to conduct clinical
trials of human pluripotent stem cells based product for the treatment of
Parkinson’s disease. We believe the outcome of the study will produce findings
in-line with our preclinical studies, where we demonstrated not only safety of
our proprietary neural stem cells, but also their functional efficacy. The
cells were able to successfully integrate into the brain and provide a
significant increase of dopamine levels in the nigrostriatal system” commented
Russell Kern, PhD, ISCO’s executive vice president and chief scientific
officer.
For more information, visit www.internationalstemcell.com
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