"We are excited to begin the next phase of this neural stem cell trial, further evaluating safety precautions, while increasing both the number of injections and cells transplanted in ALS patients," says
This is the first U.S. clinical trial of stem cell injections into the spinal cord for the treatment of ALS. The study is jointly funded by a
The Phase I trial, conducted exclusively at
"In the Phase II trial, the first 12 patients will receive injections in the cervical spinal cord only, the region that may help in preserving breathing function," says Glass, who is a longtime ALS researcher and clinician. "The final three patients will receive both cervical and lumbar injections. The dose will also increase in both number of injections and cells per injection throughout the trial."
In Phase I, the trial progressed to a maximum of 15 injections of 100,000 cells each. In Phase II, the trial will advance up to a maximum of 40 injections and up to 400,000 cells per injection.
"We hope this trial continues to foster the development of both new techniques for surgical implementation and treatments for people who are living with ALS," says Boulis. "The Phase II trial will help us better understand if more injections with more cells can improve conditions for the patient in a safe manner."
A skilled neurosurgeon, Boulis is teaching other neurosurgeons involved in this trial the proper procedures for implanting human neural stem cells.
ALS is a fatal neurodegenerative disease with no known cure. It causes the deterioration of specific nerve cells in the brain and spinal cord called motor neurons, which control muscle movement. As the illness progresses, patients lose their ability to walk, talk and breathe. According to the
Boulis is the inventor of technology related to this study. He receives licensing fees from
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