(By Balaseshan) Neuralstem Inc. (NYSEAMEX: CUR), which develops treatments for central nervous system disease, said it has received approval to begin ischemic stroke clinical trial in China with its spinal cord stem cells.
The company, through its subsidiary - Neuralstem China (Suzhou Neuralstem Biopharmaceutical Co. Ltd.) - will commence a clinical trial to treat motor deficits due to ischemic stroke with its spinal cord stem cells at BaYi Brain Hospital in Beijing.
The trial approval includes a combined phase 1 and 2 design, and will test direct injections into the brain of NSI-566, the same cell product tested by Neuralstem in a recently-completed phase IALS trial in the United States.
The trial is expected to begin early next year. Ischemic strokes, the most common type of stroke, occur as a result of an obstruction within a blood vessel supplying blood to the brain. Post-stroke motor deficits include paralysis in arms and legs and can be permanent.
The trial is designed to enroll up to 118 patients who have suffered an ischemic stroke with chronic residual motor disorder. The stem cell treatment involves a one-time treatment of intracerebral injections of Neuralstem's neural stem cells into the stroke area using well-accepted stereotactic injection procedures.
The trial will be conducted in two parts. The first part of the study, phase 1, will be open-label and enroll up to 18 patients who will be assigned to three cohorts. Each of these will receive ascending doses of NSI-566 to define the maximal safe dose. The maximal safe dose defined in the first phase will be used to evaluate efficacy in the second part of the study, a Phase two proof-of-concept study.
This phase will be a multi-site, randomized, controlled, single-blind study and enroll up to 100 randomized subjects. Half of the subjects will receive a one-time treatment with the cells and physical therapy and the other half will receive only the physical therapy with no surgery.
Outcome measures during the follow-up period in phase two will be conducted in a single-blinded manner. The combined study, including patient monitoring and data collection, is expected to take about two years.
CUR is trading up 3.42 percent at $1.24 on Thursday. The stock has been trading between $0.42 and $1.96 for the past 52 weeks.