We have identified NSI-566, a stable neural stem cell line, isolated and expanded from a single human fetal spinal cord tissue, as the investigational product for TBI treatment.NSI-566 has been approved by the US FDA as an investigational product for clinical testing in ALS (IND# 13905) and chronic SCI (IND# 14413) which are ongoing.For TBI treatment, we propose to place deposits of NSI-566 into the peri-lesion areas of the brain by intraparenchymal injections using a stereotactic frame and a brain injection cannula. The therapeutic goal would be to improve/reverse motor deficits, i.e., paralysis, primarily.Our aim is to submit a pre-IND meeting request to the Division of Cellular and Gene Therapies (DCGT) at the Office of Tissues and Advanced Therapies (OTAT)/CBER/FDA to confirm our plan for IND-enabling studies, which will be proposed for the SBIR Phase II grant.Submission of the IND for a Phase I/IIa clinical study to treat chronic motor deficits due to severe TBI will be the aim of the SBIR Phase II.
