|Human Neural Stem Cells |
Differentiating Into Neurons
The cell bank contains over 2.6 billion human cells, sufficient to meet the company's foreseeable clinical trial requirements.
"Completing the production of clinical-grade cells using the previously published protocol is one of the final steps before starting our clinical program. Because of the complexity involved in manufacturing live human cell products, having our own GMP 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." said Ruslan Semechkin, Ph.D., ISCO's Chief Scientific Officer.
ISCO's master cell bank of human parthenogenetic neural stem cells (ISC-hpNSC) is produced 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.
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. The existing master cell bank and current production scale are sufficient to supply our anticipated product needs through pivotal clinical trials. The cell bank was produced at the company's state of the art GMP manufacturing facility located in Oceanside, Calif.