Summary: A Phase I clinical trial has demonstrated the long-term safety of neural stem cell transplantation for chronic spinal cord injuries. Researchers followed four patients for five years, with two showing sustained neurological improvements, including better motor function and sensory responses.
Neural stem cells, derived from human cells, can integrate into the nervous system and promote tissue repair. The results suggest therapeutic potential, and the team plans to move forward with a Phase II trial to assess treatment efficacy.
Key Facts
- Long-Term Safety: All four patients tolerated neural stem cell transplantation well.
- Neurological Gains: Two patients showed improved motor function, sensation, and EMG activity.
- Therapeutic Potential: The results pave the way for a Phase II trial to evaluate treatment efficacy.
Source: UCSD
A Phase I clinical trial led by researchers at University of California San Diego School of Medicine has demonstrated the long-term safety and feasibility of neural stem cell transplantation for treating chronic spinal cord injuries.
These devastating injuries often result in partial or full paralysis and are currently incurable.
The study, which followed four patients with chronic spinal cord injuries for five years, found that two patients showed durable evidence of neurological improvement after treatment with neural stem cell implantation, including increased motor and sensory scores, and improved electromyography (EMG) activity. Some patients also showed improvement in pain scores.
Neural stem cell transplantation is an emerging treatment for various neurological disorders and injuries that works by implanting human-derived stem cells into damaged or diseased areas of the nervous system.
Because these neural stem cells are derived from human cells, this treatment approach has the potential to regenerate damaged tissue while integrating seamlessly into the existing nervous system.
The study found that all four patients tolerated the treatment well, and while the current study was only designed to assess safety and tolerability, the results suggest that neural stem cell transplantation may have therapeutic potential for treating chronic spinal cord injuries.
Following these promising results, the researchers now hope to initiate a phase II clinical trial to assess the treatment’s efficacy.
The study, published in the December 17 edition of Cell Reports Medicine, was led by Joseph Ciacci, M.D., a professor in the Department of Neurological Surgery at UC San Diego School of Medicine and neurosurgeon at UC San Diego Health, and Joel Martin, M.D., who was a neurological surgery resident physician at UC San Diego at the time the study was completed and is now a neurosurgeon at Orlando Health.
Funding: 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.
About this stem cell transplantation and SCI research news
Author: Miles Martin
Source: UCSD
Contact: Miles Martin – UCSD
Image: The image is credited to Neuroscience News
Original Research: Open access.
“Long-term clinical and safety outcomes from a single-site phase 1 study of neural stem cell transplantation for chronic thoracic spinal cord injury” by Joseph Ciacci et al. Cell Reports Medicine
Abstract
Long-term clinical and safety outcomes from a single-site phase 1 study of neural stem cell transplantation for chronic thoracic spinal cord injury
We report the long-term results for a phase 1 study of neural stem cell transplantation for chronic spinal cord injury.
The trial was registered on ClinicalTrials.gov as NCT01772810.
The primary outcome of the trial was to test the feasibility and safety of human spinal cord-derived neural stem cell (NSI-566) transplantation for the treatment of chronic spinal cord injury in four subjects with thoracic two to thoracic twelve spinal cord injury.
Here, we report that all four subjects tolerated the stem cell implantation procedure well, and two subjects had durable electromyography-quantifiable evidence of neurological improvement as well as increased neurological motor and sensory scores at five years post-transplantation.
