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FDA Approves Advance of ALS Stem Cell Trial

Neuron illustration (NIH)

(National Institute on Aging, NIH)

Neuralstem Inc. in Rockville, Maryland says the Food and Drug Administration has approved the progression of a clinical trial to broaden treatment of amyotrophic lateral sclerosis (ALS) with neural stem cells. Based on the FDA’s approval, the trial at Emory University in Atlanta can expand stem cell transplant region for treating ALS, also known as Lou Gehrig’s disease, to a second region of the spinal cord.

The company says that the FDA reviewed safety data from the first 12 patients in the study and has granted approval for the trial to advance to transplanting patients in the cervical (upper back) region. Until now, patients have received injections in the lumbar (lower back) region only. The trial is now expected to expand to the final two cohorts of patients with ALS, all of whom will be transplanted in the cervical region of the spine.

The phase 1 trial is the first study to test in humans spinal derived stem cells transplanted into the spinal cord of patients with ALS, to see if the cells and the procedure to transplant them are safe. The trial is expected to enroll up to 18 patients. The first 12 patients have been transplanted in the lower back region of the spine.

The trial will now progress to the last six patients. The first three of these will receive unilateral injections in the cervical region of the spine. The next three will receive bilateral injections in the cervical region.

The three surgeons who conducted the transplants issued a statement indicating, “All of the patients tolerated the procedure without major surgical complications, and there are no indications to date that the stem cells themselves are either toxic or injurious to the spinal cord. Our quantitative clinical assessments showed no evidence of acceleration of disease following stem cell injections, meeting our stated goal of proving safety for this Phase I trial.”

The surgeons add, “Prolongation of life for patients with ALS will require therapeutic intervention at the level of the cervical spinal motor neurons affecting respiratory function,” which requires progressing the study to the injections in the cervical spinal cord.

Read more: University Spin-Off Begins Trial of Stem Cell ALS Treatment

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