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Neuralstem Receives FDA Approval to Dose Patients in Cervical Region in Ongoing ALS Trial
Date:10/24/2011

ctors concluded, "We have successfully treated 12 ALS patients with unilateral or bilateral intraspinal injections of neural stem cells. 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. We have cautious optimism that a few of the patients may have slowed in their progression of lower extremity weakness, and one patient may have improved."

Prolongation of life for patients with ALS will require therapeutic intervention at the level of the cervical spinal motor neurons affecting respiratory function," they continued. "To reach this ultimate goal we plan to move to injections into the cervical spinal cord,  which is the next stage of this Phase I trial."

"We are very excited about the trial results to date and encouraged by the safety data," commented Lucie Bruijn, PhD, Chief Scientist, The ALS Association. "This is a very important step forward for stem cell therapy in ALS and we are fortunate to have such a committed and skilled research team at Emory and Neuralstem to move this forward. These results pave the way for the next stage of the trial and for future stem cell transplants in ALS."

"This is a major milestone for Neuralstem," said Richard Garr, Neuralstem CEO and President. "Demonstrating the feasibility and safety of transplanting our cells in the upper regions of the spinal cord will have important ramifications for our spinal cord injury program as well as ALS."

About the Trial

The Phase I trial to assess the safety of Neuralstem's spinal cord neural stem cells and intraspinal transplantation method in ALS patients has been underway since January 2010. The trial is designed to enroll up t
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SOURCE Neuralstem, Inc.
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