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news.The Safety Monitoring Board (SMB) has approved Neuralstem’s Phase I human clinical trial of spinal cord stem cells in the treatment of amyotrophic lateral sclerosis (ALS) to advance to transplantations in cervical region, after reviewing the safety data from the first twelve patients.
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All the patients received injections in the lumbar region of the spine only.
The trial plans to enroll up to 18 ALS patients, who are both non-ambulatory and ambulatory will be examined at regular intervals post-surgery.
The next three patients, all of whom are ambulatory, will each receive five injections, unilaterally, in the cervical spinal cord.
In addition to the SMB approval, the FDA must also approve the trial’s moving to the next level of transplantations.
University of Michigan Health System and Alfred Taubman Medical Research Institute director Eva Feldman said while this is still primarily a safety trial, it is their hope that cervical injections can help the patient’s breathing and swallowing, the areas which most often lead to loss of life in ALS.