Stem Cell Transplantation to Treat ALS Patients Proves Safe and Well-Tolerated
According to the phase 1 study by Neuralstem (USA), transplantation of stem cells into the lumbar region of the spinal cord has proven safe and was well-tolerated by 12 ALS patients. No long-term complications were shown by the study. Its results were published online in the peer-reviewed journal Stem Cells
The company seeks to determine whether stem cell treatment can prolong life span and improve respiratory function in ALS patients. This particular trial that started in January 2010 was conducted to assess safety of the treatment, and both spinal cord stem cells and surgical procedure to administer them into the patient’s body proved safe. In addition to that, one patient with ALS out of 12 involved in the trial showed clinical improvement, though the trial was not aimed to assess treatment efficacy.
Among 12 trial participants, 6 were unable to walk and the other 6 still had such ability. Half of the patients in each group were injected stem cells five times on one side of the spinal cord (lumbar, at the lower back), while the other half had ten injections, five per each side of the spine.
Given positive safety results of the trial, the FDA allowed Neuralstem to start injecting stem cells to ALS patients in the cervical (neck) region of the spinal cord. In March 2012, Neuralstem involved the 14th patient in the trial. This is the first woman in the trial and the second one to receive stem cells in the neck region of the spine.