The University of Michigan Health System reports that the first two amyotrophic lateral sclerosis (ALS) patients in Michigan have received experimental stem cell injections to their spinal cord.
A news release from the organization notes that the patients are the first to receive the experimental injections in Michigan as part of a national trial. The trial is designed to study the impact that injected stem cells might have on motor neurons.
The patients have returned home and are scheduled to receive follow-up monitoring and testing in an effort to allow U-M researchers to assess the safety and any potential effect of the injections. The organization also states that additional ALS patients are being evaluated for possible participation in the trial to U-M and Emory University.
The release notes that the FDA approved the Phase II trial, which is funded by Neuralstem Inc. Serving as the trial’s principal investigator is Eva L. Feldman, MD, PhD, and the Russell N. DeJong professor of neurology at the U-M Medical School and director of the A. Alfred Taubman Medical Research Institute.
The study follows data presented earlier this year in a Phase I trial conducted at Emory University. The trial results suggested that spinal cord injections of 100,000 cells were delivered safely and tolerated well. Researchers also added that they observed possible signs that in one patient subgroup, ALS progression may have been interrupted. Feldman states that in Phase II of the trial, researchers will be permitted to give more injections and more stem cells. Parag Patil, MD, PhD, a U-M neurosurgeon and biomedical engineer, reportedly performed both operations on the U-M trial participants.
The release reports that the Phase II dose escalation trial is designed to treat up to 15 ambulatory patients in five different dosing cohorts, under an accelerated dosing and treatment schedule. The first 12 patients will be divided into four cohorts and receive injections in the cervical region of the spinal cord. The first cohort of three patients received 10 cervical injections of 200,000 cells per injection. Researchers say the trial is slated to progress to a maximum of 20 cervical injections of up to 400,000 cells per injection.
According to the release, the last three patients will receive injections in both the cervical and the lumbar regions. These patients are scheduled to receive 20 injections of 400,000 cells in each lumbar region in addition to the 20 injections they will have already received in the cervical region.
Source: University of Michigan Health System