With an operation to inject stem cells into the spinal cord of an ALS patient on Oct. 2, a team at the University of Michigan completed the first stage of its U.S. Food and Drug Administration trials to test a new therapy for the deadly neurological disease.
It was the third operation to inject stem cells since the FDA gave approval last April for phase-two trials on 15 patients suffering from amyotrophic lateral sclerosis, also known as Lou Gehrig's disease.
The first operation was at Emory University Hospital in Atlanta, with the next two at UM.
The recent operation, like the other two, involved injecting 200,000 stem cells at each of 10 sites in the cervical region of the spine. That area regulates breathing, and most ALS patients die from breathing difficulties. An independent panel of surgeons and neurological experts not affiliated with UM will assess the first three operations for safety.
Eva Feldman, M.D., the principal investigator in the trials, which are funded in part by the National Institutes of Health and the ALS Association, expects the panel to give its approval in about a month to proceed to the next round of three operations, which will involve the injection of 200,000 cells at each of 20 sites.
In the final stage of the trial, patients will be injected with up to 8 million cells. They are from a stem cell line derived from a donated human embryo and are provided by Rockville, Md.-based Neuralstem Inc.
Feldman, director of the A. Alfred Taubman Medical Research Institute at UM and director of the ALS clinic at the UM Health System, was part of the Ann Arbor operating team, which was led by Parag Patil, M.D. Feldman's job as neurologist was to prepare the stem cells and to load them into the device that injected them into the spinal cord.
While the panel's role is to conduct ongoing safety reviews, the trial itself tests efficacy. The operations are conducted on patients who have been diagnosed in the last two years and who are in relatively good health.
The goal is to have healthy stem cells grow neurons that will halt the disease's progress, and in some cases, reduce or eliminate symptoms.
Tom Henderson: (313) 446-0337, thenderson@crain.com. Twitter: @tomhenderson2
More here:
UM completes 1st stage of stem-cell therapy for ALS