American researchers have published in the “Journal of Stem Cells” the outcome of human phase 1 clinical trial using neural stem cells. The study published said infused neural stem cells into patients with chronic spinal cord injuries showed measurable improvement in 3-4 subjects, with no other complications.
The trial included four participants receiving 6 injections each containing 1.2 million neural stem cells. All the 4 participants had 1-2 year old permanent injuries of T2-T12 spine. This trial aimed at safety and made sure there were no procedure related complications in any patient. The study was piloted by Joesph Ciacci, the principal investigator of Neurosurgeon University of California, San Diego School of Medicine.
John Ciacci said that in conclusion they were sure that their trial was safe and can be safely performed with early signs of efficacy. Future exploration and dose escalation studies were also on the progress.
Earlier the same study was done on animal subjects with spinal cord injury and it resulted in neuronal regeneration after infusion of stem cells. The animals (rats) also improved in function and mobility.
The human clinical trial showed results that were not very dramatic but it was encouraging when the participants were followed for 18 to 27 days after transplant. The analysis of motor, sensory and electrophysiology showed improvement of function in 3 of the 4 participants.
Though the sample size was small the strength of the study was extensive. Everyone was treated for a year after injury and only patients with scope of improvement were taken. This treatment having shown considerable improvement is a much awaited breakthrough.
Dr. Ciacci said they would like to begin this trial with patients with spinal cord injuries as well.