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).
Stem cell clinical trial- has this been posted yet? 
