Clinical trials: Noncellular regenerative approaches

This chapter will provide an overview of the current noncellular regenerative therapies used in clinical trials as part of treating spinal cord injury (SCI). These methods include the use of antibodies, growth factors, minerals, drugs, biomaterials, and electrical stimulation, which aim to assist the endogenous regenerative circuitry to promote repair and replacement of cellular loss and axonal discontinuity. Most treatments demonstrate safety and feasibility for implementation in SCI; however, further testing is still required to determine efficacy in different clinical subpopulations. This chapter delves into clinical trial phases one to three, as well as humanitarian device exemption studies, with a focus on those from North America, Europe, Japan, and Australia. The trial objectives, main inclusion criteria, and available published results are examined.