Lessons Learned and Recommendations from a SCOPE Spinal Cord Injury Neurorestorative Clinical Trials Update.

Area of Science:

• Neuroscience
• Regenerative Medicine
• Clinical Trials

Background:

• The Spinal Cord Outcomes Partnership Endeavors (SCOPE) convened a clinical trials update (CTU) preceding their annual meeting.
• This event, in collaboration with the International Spinal Research Trust, focused on novel neurorestorative approaches for spinal cord injury.

Purpose of the Study:

• To present updates on selected clinical trials prioritizing novelty and neurorestoration.
• To facilitate discussion on practical aspects of clinical translation and lessons learned from ongoing and completed trials.
• To identify strategic directives for future spinal cord injury research.

Main Methods:

• 13 speakers presented 12 trials (4 in-preparation, 4 in-progress, 4 completed).
• Discussions emphasized trial novelty, strengths, translation, and lessons learned, rather than recapitulating published data.
• Global participation via live stream and in-person attendance from 1600+ individuals.

Main Results:

• Presentations covered diverse therapeutic modalities: drug, biological, and device-based.
• Key discussion themes included outcome measure suitability, clinical meaningfulness, novel trial designs, and rehabilitation's role.
• Emphasis was placed on robust pre-clinical data and integrating lived experience.

Conclusions:

• Strategic directives were summarized to address challenges in spinal cord injury clinical translation.
• Future trials should focus resources on effective steering, informed by lessons learned.
• Integrating patient-reported outcomes and tailored approaches is crucial for meaningful progress.