Chronic spinal cord injury (SCI) is a debilitating condition with few effective treatments. These injuries can completely change the quality of a patient’s life. Patients may struggle to engage in their everyday activities, deal with the loss of sensory function, paralysis, and more. SCI patients are looking for any type of relief from these symptoms.
Current therapies focus on symptom relief rather than any sort of significant improvement in motor or sensory function. There are currently no treatments that would lead to significant improvements in motor and sensory functions. The medical community is looking into other potential therapies for spinal cord injury patients.
Stem cell therapy represents a potential new treatment option for chronic SCI. The unique properties of stem cells represent hope for spinal cord injury patients who are left with few treatment options. The hope is that stem cells can repair some of the damage that the original injury caused.
A study, A First-in-Human, Phase I Study of Neural Stem Cell Transplantation for Chronic Spinal Cord Injury, looked into the potential of stem cell therapy for SCI. This study reports the first-in-human application of neural stem cells for the treatment of chronic SCI. The safety and feasibility of this approach was assessed in a small cohort of patients with chronic SCI.
The Results of the Study
The potential of stem cell therapy to improve SCI patient outcomes has excited researchers for some time. There are multiple preclinical studies that showcase the promise of stem cell therapy for SCI patients. The researchers researched various preclinical studies on rats with spinal cord injuries who were treated with stem cells. The researchers came to the conclusion that stem cells can be a potentially effective treatment for SCI patients.
Four patients received NSI-566 spinal cord implantation. Patients received a total of six injections of stem cells over the course of six to eight days. The researchers evaluated patients based on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) scores, functional and pain surveys, SCIM scores, electromyography (EMG), Brain Motor Control Assessment (BMCA), and serial MRI.
The results from the study were extremely promising. There were no adverse reactions to the treatment. Patients did not have any post-cell injection inflammatory change, swelling, or fluid accumulation. This outcome was one of the primary goals of the study. Three patients, in particular, showed progress in regard to the researchers’ evaluation methods.
A 26-year-old female patient who suffered a motor vehicle accident received stem cell treatment. The patient showed ISNCSCI score improvements of two-level sensory and motor improvements at 6, 12, and 18 months. There was a one-level sensory and motor improvement at 27 months. The BMCA showed that the patient developed new muscle responsiveness in the lower limbs. The patient went from a complete SCI status to an incomplete SCI status.
The second patient was a 33-year-old male patient who suffered an SCI after a motorcycle accident. The patient showed progress even though there was no initial change in ISNCSCI neurological score. The 12-month EMG analysis showed new voluntary activity in the right rectus abdominis and left T6 to T8 paraspinal muscles. The results also led the development of sensation between T6 and T9 bilaterally.
Another patient, a 24-year-old male who suffered an SCI after a motor vehicle accident, also received treatment. After receiving the treatment, the patient had ISNCSCI score improvement of one-level sensory and motor improvement from T5 to T6 on the right side and two levels of sensory and motor improvement from T5 to T7 on the left side. This improvement was noted at 6, 12, and 18 months after the treatment.
The 26-year-old saw improvement in voluntary bilateral motor control of T6 to T7 abdominal wall muscle. EMG analysis showed activity in the right superficial paraspinal muscle at T7 where there was previously none. The last patient did not show improvements in ISNCSCI scores 12 months after receiving treatment. Unfortunately, there were no significant changes in quality of life scores.
Overall, the study was promising as patients saw improvements in ISNCSCI scores as well as activity of new muscle development and movement. The researchers believe that the patients began to develop new neurons that can help improve patient outcomes. The goal of the study, to establish safety and tolerability, was achieved.
The study concluded that more research needs to be performed in order to obtain more data on how SCI patients respond to stem cell therapy. This study represents another step forward in the development of stem cell therapy for SCI patients.
