A groundbreaking multi-center clinical trial known as the NISCI trial (Nogo-A Inhibition in acute Spinal Cord Injury Study) has revealed that the antibody NG 101 (anti-Nogo-A)—which blocks the body’s own Nogo-A protein—can significantly enhance motor function recovery in patients with acute spinal cord injuries. These findings were recently published online in the prestigious journal The Lancet Neurology.
Understanding Nogo-A and Its Role in Spinal Cord Injuries
When a spinal cord injury occurs, the Nogo-A p<>rotein naturally inhibits the regeneration of damaged nerve fibers. In multiple animal studies, scientists observed that this protein slows the body’s capacity to restore nerve pathways after injury. By neutralizing Nogo-A with the NG 101 antibody, researchers aim to reduce these inhibiting mechanisms, potentially allowing the injured nerve tracts to regenerate and the spinal cord to heal more effectively.
Key Findings from the NISCI Trial
Study Design and Participants
Participants: 126 people aged 18 to 70 with acute, complete-to-incomplete spinal cord injuries in the cervical (neck) region. This type of injury, known as tetraplegia, affects arm and hand function.
Treatment Groups: 78 participants received the NG 101 (anti-Nogo-A) antibody injected directly into the spinal canal, while 48 received a placebo.
Treatment Cycle: Each participant underwent a full cycle of six injections, in addition to comprehensive inpatient care.
Randomized, Double-Blind, Placebo-Controlled: Neither the participants nor the healthcare professionals administering the injections knew who received the actual antibody versus placebo.
Improvements in Incomplete Spinal Cord Injuries
Motor Function Assessment: The study used standardized methods to measure motor function recovery in the hand-arm muscles—critical for independent daily activities in individuals with tetraplegia.
Results:
Complete Injuries: No notable difference in motor function recovery.
Incomplete Injuries: Significant improvement in voluntary muscle activation and functional independence in daily life among those who received the anti-Nogo-A antibody.
Safety and Tolerability
Well Tolerated: The antibody was generally well tolerated, with no related side effects reported.
Research Milestone: These encouraging results reflect years of antibody research and rehabilitation studies led by Balgrist University Hospital, demonstrating promising avenues for enhancing recovery after acute spinal cord injury.
Next Steps: Further Studies and Improved Antibodies
While these positive clinical findings mark an important milestone, they must be validated by additional research. A follow-up study featuring an optimized antibody is scheduled to begin in December 2024. Based on the current results, researchers plan to focus on patient subgroups most likely to respond favorably to the treatment, aiming to maximize therapeutic outcomes.
European Collaboration for Spinal Cord Injury Research The international NISCI trial was a joint effort by: University of Zurich (Prof. Martin Schwab) Balgrist University Hospital in Zurich (Prof. Armin Curt) Heidelberg University Hospital (Prof. Norbert Weidner), responsible for the publication in The Lancet Neurology Conducted within a European clinical network, the trial leveraged specialized centers across Germany, Switzerland, Spain, and the Czech Republic to recruit and treat patients with spinal cord injuries. This collaboration will continue with the upcoming follow-up study. Funding and Production of the Test Antibody Production of NG 101: Enabled through the CeNeReg project in partnership with the Regenerative Medicine Technology Platform of the Wyss Zurich Translational Center. Financial Support: EU’s Horizon 2020 Research and Innovation Programme Swiss State Secretariat for Education, Research and Innovation (SBFI) Swiss Paraplegic Foundation Wings for Life research foundation “CeNeReg” project (Wyss Zurich, University of Zurich, ETH Zurich) “International Research in Paraplegia” foundation Why This Research Matters for Spinal Cord Injury Patients Potential for Enhanced Recovery: By targeting Nogo-A and potentially other inhibitory factors, scientists may help restore critical motor functions, improving daily life activities for people with spinal cord injuries. Future Therapeutic Pathways: Continued studies will refine antibody-based treatments, paving the way for personalized medicine approaches that consider the type and severity of spinal cord injuries.