Next-gen spinal cord injury clinical trials: lessons learned and opportunities for future success

Abstract

Despite promising basic science discoveries and a surge in clinical trials, the quest for effective treatments that restore neurological function after spinal cord injury lags on. While "failed" in a conventional sense, emerging solutions to longstanding challenges represent promising steps towards a future with effective interventions. In this personal view, we highlight clinical trials implementing new solutions and their impact on the field. Our perspective is that, ultimately, the integration of shared knowledge, adaptive designs, and a deeper understanding of the intricacies of spinal cord injury holds promise of unlocking of major breakthroughs, leading to improved outcomes for people with spinal cord injury.

Keywords: Adaptive design; Neurorestorative trials; Spinal cord injury clinical trials.

Fig. 1

The spinal cord injury clinical trial landscape. Clinical trials in spinal cord injury have evolved from a handful of historical trials in the 1980s, followed by the start of the cell-based era, and more recently, a surge in next-gen trials demonstrating emerging opportunities for future success. ∗Note: This illustrates a selection of clinical trials covered in this Personal View, not a complete list of clinical trials in spinal cord injury.

Fig. 2

Overview of clinical trials in spinal cord injury. A. The majority of neurorestorative trials are in the United States (231), followed by Canada (41), Switzerland (20), Spain (19), China (18), and the United Kingdom (18). Multi-centre trials that include different countries are counted for each country. B. The most common primary intervention type is technology (e.g., spinal cord stimulation) (223), followed by rehabilitation (83), drug (49), and biological/cell-based trials (23). C. A total of 195 neurorestorative trials are currently recruiting, 27 are recruiting soon, 11 are recruiting by invitation, and 107 have ended. Please note that the numbers displayed in this figure reflect the trials identified in the search criteria described in the ‘Search strategy and selection criteria’ section.

Fig. 3

Current challenges and emerging solutions in spinal cord injury clinical trials. Challenges of traditional clinical trials in spinal cord injury (SCI) (A) and their corresponding solutions that have emerged in Next-gen clinical trials (B) demonstrate fruitful ground for future success in spinal cord injury trials.