To date, the goals of spinal surgery have been easy to define: to ‘decompress’, to ‘realign’ and to ‘fuse’. More recent refinements have been directed towards two new goals: to ‘preserve’ and to ‘protect’. Preservation of the enveloping soft tissues minimises bleeding and scarring, and reduces pain. This can be facilitated by minimal and alternate access surgery, using techniques such as percutaneous pedicle screw insertion, transpsoas and transsacral vertebral access and endoscopic scoliosis correction. Protection of the neural elements improves the safety of spinal surgery and allows the surgeon to perform more complex procedures. Methods have been developed to accurately guide the surgeon to the target structure or pathology while avoiding neural structures, and to monitor spinal cord and nerve function. Both approaches allow safer instrumentation and deformity correction. In the past, protection of important structures has been achieved by wide exposures, sacrificing preservation of soft tissues. As this shortcoming has been recognised, techniques have been developed that have radically reduced wound size but often compromised vision and put neurovascular elements at risk. Refinements have attempted to balance these goals. At present, we have a variety of techniques available to us but were hare hampered by cost and complexity. The future will hopefully bring further improvements but perhaps new ideas and approaches that challenge our current concepts of invasive spinal surgery.
In a single-blind, Phase I clinical trial, we aimed to test the feasibility and safety of transplantation of autologous olfactory ensheathing cells into the spinal cord of three humans with complete spinal cord injury. This paper describes the trial and the surgical procedures and presents twelve month safety data.
Olfactory ensheathing cells were harvested from each subject in the surgery group, grown and purified All patients are tested on enrollment and then at regular intervals up to three years by a group of assessors who are blinded to the treatment or control group status. These assessments include physical, radiological, neurophysiological and psychosocial parameters.
This is the first reported trial of OEC’s in human spinal cord injury. Twelve-month data in a small cohort shows that there is no evidence of adverse events that would preclude completion of the current trial and the development of efficacy trials.
At an average follow-up of 36 months all patients reported good relief of their symptoms, and had returned to their best function post-injury.