CELLTOP: A Phase I Clinical Trial of Autologous Adipose Derived Mesenchymal Stem Cells in the Treatment of Paralysis due to Traumatic Spinal Cord Injury
Grant Project Details:
This clinical trial investigates whether adipose-derived (fat tissue-derived) mesenchymal stem cells can be safely administered into the cerebrospinal fluid of patients with traumatic spinal cord injury and what the effects this may have on functional improvement, activities of daily living, and quality of life. If successful, this study may create a viable clinical option for spinal cord injury patients by establishing feasibility and safety data for patients who do not have many treatment options.
In the current clinical trial, we are investigating the role of fat-cell derived mesenchymal stem cells (a type of stem cell found all over the body in multiple different tissue types) injected intrathecally (i.e., into the spinal canal) among patients who have suffered a spinal cord injury. This research study is being conducted at the Mayo Clinic in Rochester, MN where nearly one-third of MSC clinical trials across the nation are conducted and approximately 200 patients with spinal cord injury are treated on an annual basis.
In the first year of our clinical trial, our team has enrolled a total of 10 patients with spinal cord injury. Of those 10 subjects, 7 subjects have been treated with 3 subjects remaining to be treated. All treated subjects have successfully moved through the acute phase of treatment with no serious adverse events and demonstrating promising preliminary results. This research study has created two positions vital to the project and future studies that will spin-off this clinical research trial. At each follow-up visit, we learn more and more about spinal cord injury, which patients may benefit from this study, and how best to shape the future of clinical care and practice for our patients. Future work involves understanding the effect of multiple stem cell doses over the course of one year in patients suffering from spinal cord injury. Future studies will also include the combination of multiple treatment modalities to maximize recovery and independence in our spinal cord injury population.
Grant Awardee Biography
Dr. Bydon is a neurosurgeon who is fellowship-trained in complex spinal surgery and spinal oncology. He is a principal investigator of the Mayo Clinic Neuro-Informatics Laboratory and the medical director of the Mayo Clinic Neurosurgical Registry, a database focused on improving outcomes and safety for patients.