Large scale production of neural stem cells for spinal cord injury treatment

Approximately 250,000 people in the United States live with chronic spinal cord injuries (SCI).  Annually, there are between 12,000 and 20,000 new patients with SCI.  Though there are many treatments currently available for this injury, total motor and neural function restoration is not typically achieved.  As a result, a therapeutic able to aid in spinal cord restoration and remain compliant with current federal regulations is desired.

Recently, use of neural stem cells for treatment of this injury has been investigated because of the cell’s multipotency and its ability to aid in spinal cord repair.  Mesenchymal stem cells are able to differentiate into neural stem cells and can be separated from discarded umbilical cord tissue with relative ease. 

Discovering and obtaining proof of concept and then efficacy and safety for life improving therapeutics is only part of the path to bring products to the patients.  The ability to make quantities large enough for clinical trials and then to meet commercial targets is a challenge especially in the area of stem cells. This work explores a proposed manufacturing process and facility design for a target market of 15,000 patients per year.  With new treatments and ways to manufacture those treatments, it is believed that individuals with ailments such as spinal cord injuries will have a better quality of life.