Design of a Large-Scale Clinical Trial for the Treatment of Spinal Cord Pain Using Stem Cell Therapy

Abstract

As of April 2009, there are over 13, 500 cases of spinal cord injury (SCI) per year in North America alone, exceeding $9 billion in annual treatment costs. Current therapies focus on masking the pain of spinal cord injury rather than restoring lost function. In the current report, a stem cell therapy is proposed for functional restoration of spinal cord injury using multipotent human neural stem cells (hNSCs).

The process involves 4 stages. In the first stage, Cell Preparation, hNSCs are extracted from human tissue and cultured in small-scale bioreactors. The second stage, Bioreactor Expansion, focuses on the large-scale expansion of hNSCs in 500 mL computer-controlled suspension bioreactors from 102 to 109 cells. The third stage, Neural Differentiation, exposes hNSCs to valproate to produce GABAergic neurons. Finally, the cellular product is transplanted into the patient using Single-Cell Image-Guided Transplantation.

The whole process is located in the surgical suite of a hospital for optimal integration of bioprocessing and clinical application. The bioreactor facility will be 216 square feet; the neurosurgical suite will include intra-operative and magnetic resonance technology. The initial capital investment is $6 million, the annual operating cost will be $7 million, for a project cost of about $28 million. The facility will treat 104 patients per year for a trial period of 3 years. This is a leading edge treatment facility that has potential to pioneer a new kind of medicine: functional recovery using stem cell therapy using stem cell therapy.