SCSNZ Clinical Trial
The Trial will involve measuring the amount of benefit produced by spinal cord surgery involving a tissue transplantation procedure. Specialised tissue from the upper nose that provides part of the sense of smell will be used. This tissue - called olfactory tissue, has special cells known as OEC’s that provide guidance signals to help nerve fibres grow and to maintain a healthy state. Small amounts of the olfactory nose tissue will be transplanted to the site of spinal cord injury. Before implanting the olfactory nose tissue the spinal cord surgery will be opened at the injury site and much of the scar tissue will be removed. The tissue transplanted will come from the same person so that problems of transplant rejection and spread of viruses will not be present.
This is a first for New Zealand but the procedure to be tested was developed overseas in Portugal and has been performed in several other countries. The previous trials have provided information on safety and risks from the procedure but have not been set up properly to confirm the effects from the treatment. The New Zealand trial is aimed at measuring the amount of benefit obtained.
Previously published studies on this tissue transplantation procedure in people with spinal cord injury have reported some improvements. The amount of benefit in different people has varied. Some have regained sensation and muscle function over several spinal levels below the site of the spinal cord injury. Others have had no benefit. It is expected that responses will be variable in the NZ trial. Recent findings suggest that the type of rehabilitation treatment undertaken is important for determining the amount of benefit.
The New Zealand trial has been designed to measure the effect of the transplantation plus rehabilitation treatment versus rehabilitation treatment alone. This is an important question that can only be answered in a trial that is properly designed and carried out. The trial will run for approximately 2½ years. Volunteers with complete spinal cord injury in the thoracic area will be recruited for the trial. It is the first of what is planned to be a series of trials of treatment interventions in people with spinal cord injury. The goal of SCSNZ clinical trials is restoration of lost spinal cord function. They are not simply aimed at rehabilitation although that will be a supporting part of the trials.
People who wish to take part in the Trial will receive full information about the procedures and the possible benefits as well as details of risks. The detailed information sheet will be available for downloading from the SCSNZ website when the Trial is underway.