"On September 21st, 2009 Neuralstem , Inc (www.neuralstem.com) announced FDA approval for a phase I trial of spinal cord derived stem cells as a therapeutic intervention for patients with ALS. Now that we have approval from the FDA, our proposal will be submitted to Emory’s Human Investigations Committee for approval. This process to ensure the safety for our patients will take several weeks or possibly months, and we will keep this site updated with our progress. At this time, we do not have a date when we plan to release details of the proposed trial, including selection of participants."
Neuralstem Press Release
Some PALS' comments regarding the news:
"No mention of how long the treatment's effects carried on in the lab animals, if or when they relapsed...or of side-effects. Everything I've heard so far is that the results are only temporary, and the effects incomplete. Any news or links that would give us more details?"
"This is a 24 month trial. they will be treating 18 people maybe. If some die in the process they will probably halt the trial. Don't wan't to be negative, but it's just so invasive. they will open up the spine and give injections into the spinal cord."
"I was told at clinic that they would be forcing the needle into the spine and then pulling it back to make room for the cells that would then be injected. I'm not sure how much damage will be done by sticking the needle into the spine. Also they will be making several injections along the spine as the cells don't gravitate. Not being a scientist I don't know why this is so important other than we have ALS everywhere and it seems they believe it is necessary based on their findings in animals. I just wanted to post what was on the article that I recently read. Neuralstem's patented technology enables, for the first time, the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells into mature, physiologically relevant human neurons and glia. The company is targeting major central nervous system diseases including: Ischemic Spastic Paraplegia, Traumatic Spinal Cord Injury, Huntington's disease and ALS. Neuralstem plans to initiate a Phase I clinical trial to treat ALS with its stem cells. hope this helps."