Transplantation of neural tissue into the functionally compromised CNS shows great promise as a treatment for stroke and other neurological disorders. The widespread clinical use of this technique is constrained by the current limited supply of neural cells suitable for transplantation. To overcome this problem, Layton Bioscience, Inc. has developed LBS- Neurons. These cells, derived from the NT2 cell line, appear by morphological, biochemical and functional criteria to behave as authentic human neurons. In preclinical studies, transplantation of these cells into animal models of stroke provided considerable therapeutic value. A pilot clinical trial is currently underway to assess the feasibility of CNS transplants of LBS-Neurons in patients with chronic stroke deficits. The current small-scale production process for generating LBS-Neurons imposes logistical limits on the availability of these cells for clinical use. We propose to overcome this limitation by developing and evaluating several alternate cell culture systems that will allow for the large scale production of LBS-Neurons. In this way, we will begin to generate quality- controlled LBS-Neurons in quantities sufficient for more extensive clinical testing and, ultimately, widespread clinical applications. PROPOSED COMMERCIAL APPLICATIONS: Neural transplantation is a promising treatment strategy, but it requires an appropriate source of cells. LBS-Neurons are pure, human neuronal cells, with a demonstrated ability to survive, mature and function when transplanted into the CNS. They are produced on a small-scale according to GMPs, but 1arge-scale production is necessary in order to realize their full clinical and commercial potential
