A Phase I clinical trial conducted by researchers at the University of California San Diego School of Medicine has shown the long-term safety and feasibility of neural stem cell transplantation for the treatment of chronic spinal cord injuries. The study, which tracked four patients for five years, indicates potential therapeutic benefits, particularly in improving motor and sensory functions. These injuries often lead to partial or complete paralysis, and current treatments are limited.
The study, published in Cell Reports Medicine, found that two patients experienced durable neurological improvements following neural stem cell implantation. These improvements included increased motor and sensory scores, as well as enhanced electromyography (EMG) activity. Some patients also reported a reduction in pain.
Neural stem cell transplantation involves implanting human-derived stem cells into damaged areas of the nervous system. These cells have the potential to regenerate damaged tissue and integrate into the existing nervous system, offering a novel approach to treating neurological disorders and injuries.
Key Findings from the Phase I Trial
The trial's primary objective was to assess the safety and tolerability of neural stem cell transplantation. All four patients tolerated the treatment well, suggesting the procedure is safe for long-term use. While the study was not designed to evaluate efficacy, the observed neurological improvements in two patients are promising.
"The results suggest that neural stem cell transplantation may have therapeutic potential for treating chronic spinal cord injuries," said Dr. Joseph Ciacci, a professor in the Department of Neurological Surgery at UC San Diego School of Medicine and lead author of the study.
Next Steps: Phase II Clinical Trial
Building on these encouraging results, the researchers are now planning to initiate a Phase II clinical trial to rigorously assess the efficacy of neural stem cell transplantation. This trial will provide more definitive data on the treatment's ability to improve neurological function in patients with chronic spinal cord injuries.
The research was supported by the California Institute of Regenerative Medicine (CIRM) UC San Diego Alpha Stem Cell Clinic and the Sanford Stem Cell Clinical Center within the Sanford Stem Cell Institute.
