First ALS Stem Cell Trial to Commence, Neuralstem (AMEX: CUR)
Neuralstem is a biotechnology company focused on developing and commercializing human neural stem cell technology in the field of regenerative medicine primarily in the United States. Updating our post from 12/10/09. CUR announced 12/18/09, that its Phase I trial to treat Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig’s disease) with its spinal cord stem cells was been approved by the FDA and now by the Institutional Review Board (IRB) at Emory University in Atlanta, GA.
Market Opportunity: 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. CUR is targeting major central nervous system diseases including: Ischemic Spastic Paraplegia, Traumatic Spinal Cord Injury, Huntington’s disease and Amyotrophic Lateral Sclerosis (ALS), often referred to as Lou Gehrig’s disease.
Regulatory Status: This Phase I trial will primarily evaluate safety of the cells and surgery procedures utilized. The trial will ultimately consist of 18 ALS patients with varying degrees of the disease.
Bottom Line: Neuralstem’s patented technology enables, for the 1st 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:
- This is the first ALS stem cell trial in the US,
- The FDA has approved the 1st stage of the trial, which consists of 12 patients who will receive 5 to 10 stem cell injections in the lumbar area of the spinal cord.
- This trial will study the safety and the surgical procedures and devices required for multiple injections of cells directly into the grey matter of the spinal cord,
- Expects to be treating patients with stem cells in Q1/10,
- The patients will be examined at regular intervals post-surgery with final review of patient data in 24 months,
- Momentum from stem cell trials will renew interest in the sector and share price appreciation.
