StemCells Inc. is conducting a Phase I/II clinical trial of human central nervous system stem cells (HuCNS-SC) therapy in Switzerland, at the Balgrist University Hospital, University of Zurich, in order to determine if the single dose intramedullary transplantation of HuCNS-SC cells in the thoracic spinal cord is both safe and efficient in treating patients with sub-acute spinal cord injury.
This study will enroll 12 patients between the age of 18 years and 60 years, who suffered the injury at least 6 weeks prior to screening for inclusion in this study—based on the American Spinal Injury Association (ASIA) level determination assessed by the principal investigator: Dr. Armin Curt, MD.
The main endpoint being to assess safety and efficiency of one dose, the number of patient seems right since age, gender, duration of injury and ethnic backgrounds are not real variables—making the results of this study statistically significant. However, it is a single group experiment with open label, which means that the placebo effect is not taken into account (I guess it is appropriate in this case?). It is good to remember that this study is very preliminary.
Furthermore, the study subjects will receive immunosuppression for nine months following transplantation in order to minimize rejection and will be followed for one year following transplantation and then will be enrolled in a separate long-term follow-up study for an additional four years. There are further safety issues for the patients that the researchers might want to include in their study, the environment the patients will be in for the duration of receiving immunosuppressants; it could affect results.
This study is very promising and might open new doors to treating spinal cord injury–I am impatient to find out what happens.