International Stem Cell Corp. ($ISCO) Completes Master Stem Cell Bank in Preparation for Upcoming Parkinson’s Disease Clinical Trial
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
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
