Amyotrophic Lateral Sclerosis (ALS) Support Group

The following was released Monday, September 21, 2009
May it bring you some hope.
Monday, September 21, 2009, 10:47am EDT | Modified: Tuesday, September 22, 2009, 3:10am
Neuralstem wins FDA approval for ALS stem cell trialWashington Business Journal - by Tucker Echols Staff Reporter
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Neuralstem Inc. has received the green light to begin the first human stem cell trial to treat Amyotrophic Lateral Sclerosis (ALS), often referred to as Lou Gehrig’s disease. The company’s stock soared on the news.

ALS is fatal neurodegenerative disease that kills by paralysis. Currently there is no effective treatment or cure for the 30,000 people in the U.S. suffering from the disease. About 7,000 new ALS diagnoses are made every year.

Neuralstem said that the Phase I trial winning the Food and Drug Administration’s blessing would study the safety of Neuralstem's cells and the surgical procedures and devices required for multiple injections of Neuralstem's cells directly into the grey matter of the spinal cord of human patients with varying degrees of the disease.

Twelve patients will receive five-to-ten injections of Neuralstem’s patented human neural stem cells in the lumbar area of the spinal cord. In addition to establishing the safety and feasibility of the treatment, Neuralstem hopes to be able to measure a slowing down of the ALS degenerative process. Final results from the trial are expected in approximately two years.

Neuralstem said the trial will be under the direction of principal investigator Dr. Eva L. Feldman, Director of the University of Michigan Health System ALS Clinic and the Program for Neurology Research & Discovery. Feldman called the trial a major step forward in the treatment of ALS. "In work with animals, these spinal cord stem cells both protected at-risk motor neurons and made connections to the neurons controlling muscles. We don't want to raise expectations unduly, but we believe these stem cells could produce similar results in patients with ALS," Dr. Feldman said.

News of the FDA’s approval of the trial, which had been delayed in February, sent Neuralstem shares up as much as 57 percent in Monday trading. At close, Neuralstem stock (NYSE Amex: CUR) was up 21 cents to $2.08.
Posted on 09/22/09, 03:09 pm