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pocuita

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Can someone tell me if this is new info?




September 21, 2009
Neuralstem Receives FDA Approval To Begin First ALS Stem Cell Trial

Neuralstem, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to commence a Phase I trial to treat Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig’s disease) with its spinal cord stem cells.

The Rockville, MD-based Neuralstem is the first company to commence a stem cell trial to treat ALS. The trial will 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. The FDA’s approval represents a significant step toward delivering regenerative medicine directly to damaged neural cells in humans. ALS affects roughly 30,000 people in the U.S., with about 5,600 new diagnoses per year. ALS is a progressive fatal neurodegenerative disease that affects nerve cells in the brain, leading to the degeneration and death of the motor neurons in the spinal cord that control muscle movement.

“This is an extremely important trial that will test the stem cell approach in ALS in a rigorous way,” said Dr. Lucie Bruijn, senior vice president, Research and Development at The ALS Association. “This is the first stem cell trial in ALS and it will be conducted initially to study its safety for use in humans.”

Neuralstem CEO and President, Richard Garr, stated, “The beginning of our clinical trial program is a major step towards achieving Neuralstem’s goal of treating ALS, a fatal neurodegenerative disease for which currently there is no effective treatment or cure. While this trial aims to primarily establish safety and feasibility data in treating ALS patients, we also hope to be able to measure a slowing down of the ALS degenerative process. This trial will be headed by Dr. Eva L. Feldman, M.D., Ph.D., director of the University of Michigan Health System ALS Clinic and the Program for Neurology Research & Discovery, and Dr. Jonathan Glass, director of the Emory Neuromuscular Laboratory and Director of the Emory ALS Center, world-renowned for their study and treatment of ALS patients. We believe that there is no better team to conduct this study for us,” said Garr. Their participation is subject to formal IRB approval by their institutions.

“We are very excited about this clinical trial,” Feldman said. “This is a major advancement in what still could be a long road to a new and improved treatment for ALS. Feldman also directs the A. Alfred Taubman Medical Research Institute. “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 concluded.

The ALS patients will be treated through spinal injections of its patented human neural stem cells.

This first trial, which will primarily evaluate safety of the cells and the surgery procedure, will ultimately consist of 18 ALS patients with varying degrees of the disease. The FDA has approved the first stage of the trial, which consists of 12 patients who will receive five-to-ten stem cell injections in the lumbar area of the spinal cord. The patients will be examined at regular intervals post-surgery, with final review of the data to come about 24 months later.

Neuralstem expects to conduct the trial at Emory University with Dr. Jonathan Glass, M.D., Director of the Emory Neuromuscular Laboratory and Director of the Emory ALS Center, as site Principal Investigator (PI) and with Dr. Nicholas Boulis, M. D. performing the neurosurgery. The overall PI for the ALS trial program is Dr. Eva Feldman, M.D., Ph.D., Director of the University of Michigan Health System ALS Clinic and the Program for Neurology Research & Discovery.

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.

Pre-clinical work has shown Neuralstem’s cells to extend the life of rats with ALS (as reported the journal TRANSPLANTATION, October 16, 2006, in collaboration with Johns Hopkins University researchers), and also reversed paralysis in rats with Ischemic Spastic Paraplegia, (as reported in NEUROSCIENCE, June 29, 2007, in collaboration with researchers at University of California San Diego).
 

pocuita

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My dad is being treated at uofm for ALS. Can he get in this trial?

This looks like promising news!
 

psiep

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Looking forward to hearing more about this.
 

glenn gavanaugh

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finally. awesome news. crossing my fingers as tightly as possible that this is going to prove fruitful. please God, anything at this point is a Success.
 

Blackpool

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I would love to go on this trail.We should all be able to.lol
 

rocmg

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go-go neuralstem! the only unfortunate part is the results will not be know for 2 years... but i believe Neuralstem are taking their operation to Taiwan also... so maybe people will have the option of going there for treatment? i can't help sounding naive when i'm trying my best to be positive about ALS!
 

brooksea

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My husband and I are awaiting answer back from the research nurse re this trial at Emory. Will let y'all know the details and the requirements to participate.
 

Big Mike

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This is very exciting! First Brainstorm and now Neuralstem! In response to what rocmg said, yes, the Neuralstem trials in Taiwan will start next year but will go much faster than here in the states. If all goes well with the trials, treatments will be available over there in a few years. I know that's still a ways off, but it's something to hang our hats on. Don't forget about the KNS drug as well going into stage 3 of the clincial trial process next year. Let's keep our fingers crossed!
 

brooksea

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"On September 21st, 2009 Neuralstem , Inc (Stem Cell Research at Neuralstem) 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."


Jonathan D. Glass, MD Director, Emory ALS Center
 

Blackpool

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Pals can't sit around for long please make haste.
 

Erica

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To CJ:
CJ, Do you regularly go to Emory's ALS clinic, or just contacted them re: this trial?
THX.
 

brooksea

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Erica,

Emory is where we go to clinic. We normally see Dr. Glass.
 

brooksea

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This was posted at ALSTDI by steelgraham:

"There's an interesting piece about this announcement in Nature."

Here is an excerpt from the article:

However, Johe emphasized that the upcoming trial will assess safety rather than efficacy. The first few patients selected for the procedure will be those who are no longer able to walk. Because the injected cells protect rather than replace motor neurons, these sicker patients are less likely to benefit from treatment, but they are less able to lose function if something goes wrong. Cells will be injected only on one side of the spinal cord in order to minimize the number of injections into the spinal cord. Only one patient will be injected each month, so that researchers can monitor for effects over a longer period. Eventually, Johe says, the goal is to be able to inject cells in both lower and upper regions of the spinal cord in healthier patients, and see if the injections can keep motor neurons healthy.

I fail to see the logic in the above and if true, my husband would not qualify to participate.
 
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Erica

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CJ,
Thank you for your reply...
It's true that phase I trial only assess the safety; going in to phase 2 and 3 that where they looking at the efficacy.
I don't think it's necessary that phase I will be restricted to pts unable to move.
Lets hope and pray that your husband will get accepted. Erica

P.S. CJ, was your husband onset considered Limb, or bulbar? I wonder if trial Inclusion criteria might be restricted to limb onset.
 

crystalkk

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CJ,

I agree about failing to see the logic also.... Hopefully this is not true and your hubby will get in the trial.
My fingers and toes are crossed.......
 
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