A phase 1 clinical trial demonstrated the long-term safety and feasibility of neural stem cell transplantation for treating chronic spinal cord injuries. The corresponding study was published in Cell Reports Medicine.
Spinal cord injuries affect millions of people worldwide. Current treatments typically involve stabilizing the injury, preventing further damage, and rehabilitation for a potential functional recovery.
While traditional treatments include surgery and neurological rehabilitation, recent years have seen the emergence of novel approaches, including neuromodulation and cell-based therapies, such as neural stem cell transplantation.
Neural stem cell transplantation works by implanting human-received stem cells into damaged or diseased areas of the nervous system to regenerate damaged tissue and seamlessly integrate into the nervous system.
Previous studies have reported on the safety and tolerability of implanting neural stem cells into patients with spinal cord injury. In the current phase 1 trial, researchers thus evaluated the treatment on four patients with chronic spinal cord injuries who were an average age of 30 years old. Follow-ups were conducted every 6 months for five years and included pain questionnaires, quality of life assessments, brain control motor assessment, and MRI imaging.
Ultimately, the researchers found that stem cell implantation was well-tolerated by all four subjects, and that it reduced post-operative pain. Two patients also exhibited increased neurological motor and sensory scores alongside durable electromyography-quantifiable evidence of neurological improvement five years after implantation.
The researchers reported that one subject died from complications arising from sepsis, likely related to a sacral ulcer around 30 months after transplantation. They noted, however, that the event was most likely not directly attributed to the treatment or surgery.
While the findings are encouraging, the researchers wrote that the trial has some limitations. Its design as a safety trial means that the findings have no statistical power and that a control group is needed to make a full assessment of functional changes linked to neural stem cell grafting. To this end, they hope to conduct a phase 2 clinical trial to investigate the treatment’s efficacy.
Sources: Science Daily, Cell Reports Medicine