Using its patented
process, International Stem Cell has completed the manufacturing of its master
cell bank of more than 2.6 billion clinical-grade human neural stem cells. The
California biotech company says its existing master cell bank and current production
scale are sufficient to meet foreseeable clinical trial requirements, including
for the recently announced phase 1/2a clinical trial in Parkinson’s disease.
“Completing the production
of clinical-grade cells using the previously published protocol is one of the
final steps before starting our clinical program,” Ruslan Semechkin, Ph.D.,
ISCO’s chief scientific officer, stated in the news release. “Because of the
complexity involved in manufacturing live human cell products, having our own
GMP (good manufacturing practices) facility is not only a strategic advantage,
but also allows us to control the production costs. We continue to anticipate,
subject to regulatory agency approval, beginning the clinical trial in early
2015 and will provide a further update in the near future.”
ISCO’s master cell bank of
human parthenogenetic neural stem cells (ISC-hpNSC) is produced at the
company’s state-of-the art GMP manufacturing facility located in Oceanside,
California, and in compliance with current good manufacturing practices (cGMPs)
and the chemistry and manufacturing controls (CMC) discussed in the previously
reported pre-IND meeting with the FDA.
ISC-hpNSCs are a novel
therapeutic cellular product derived from the company’s proprietary human
pluripotent stem cells. The cells are karyotypically normal hpNSCs and free of
measurable contaminants of human or animal origin. The production of hpNSCs
from undifferentiated pluripotent human parthenogenetic stem cells in the
master cell bank uses qualified reagents and a standardized protocol developed
by ISCO. The undifferentiated human stem cells are derived from the
parthenogenetic line and were recently cleared by the FDA for use in clinical
trials. Each batch of hpNSC is subjected to standardized quality control
testing to ensure viability, sterility and appropriate cellular composition
before clinical use.
Neural stem cells are
self-renewing multipotent cells that are precursors for the main cell types of
the central nervous system. The ability of ISC-hpNSCs to differentiate into
dopaminergic neurons and express brain-protecting neurotrophic factors offers a
new opportunity for the treatment of Parkinson’s disease. ISCO’s preclinical
program includes animal studies to assess the safety and tolerability of its novel
cell therapy as well as doses ranging efficacy to be used to design the first
clinical trial in Parkinson’s disease patients.
For more information visit
www.internationalstemcell.com
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