A three-year, Phase I clinical trial in human paraplegics has demonstrated the safety of cells from a patient’s own nose as a possible cell therapy for spinal cord injury.
The trial was a collaboration between Queensland researchers led by Professor Alan Mackay-Sim, Director of the National Centre for Adult Stem Cell Research at Griffith University, and Dr Tim Geraghty, Director of the Spinal Injuries Unit, Princess Alexandra Hospital.
The transplanted cells were olfactory ensheathing cells, a supporting cell that normally surrounds the olfactory nerves, which were obtained through the nose by ENT surgeon, Dr Chris Perry.
There was no evidence of any complications in this trial, which involved six volunteers
with paraplegia resulting from severe spinal cord injury. Three patients were injected with olfactory ensheathing cells while the other three acted as controls. The effects of transplantation were monitored over three years.
Professor Mackay-Sim said earlier experiments in rats demonstrated the transplantation of olfactory ensheathing cells led to improved motor function.
“While the primary goal of this trial was to establish long-term safety, one of the transplant recipients did experience a measurable increase in touch sensitivity below the level of injury begining one month after the transplant and continuing throughout the trial,” he said.
“This is noteworthy and encouraging, but it is too early and the sample too small to predict efficacy in humans,” he said.
“Once the long-term safety of the transplants is established, this opens the way for efficacy trials.”
The findings were published this month in the international neurobiology journal Brain available at http://brain.oxfordjournals.org/