Neuralstem Cell Therapy

for Ischemic Stroke

  • Product status:
    • China: NSI-566 Phase I / II trial commenced in December 2013, in collaboration with BaYi Brain Hospital in Beijing
  • Mechanism of Action: Rebuilding neural circuitry lost to ischemic damage and production of factors that promote repair and recovery of surviving tissue
  • Route of Administration: Direct stereotactic injections into the brain

Neuralstem is seeking to treat paralysis in ischemic stroke patients via transplantation of its NSI-566 spinal cord stem cells directly into the patient’s brain near the stroke lesion. In an animal model of adult ischemic stroke, researchers reported that Neuralstem cells demonstrated significant therapeutic value including recovery of motor and neurological functions by high-dose transplanted stroke rats. In other preclinical animal work, Neuralstem cells were shown to be safe and well tolerated, with the cells surviving and differentiating into mature neurons in the host brain tissue.

In humans, Neuralstem will be targeting the neural circuitry that controls motor function. The proposed method of delivery will be transplantation near the motor tracts close to the stroke lesion in the brain in order to promote regeneration and repair.

Neuralstem China Phase I/II Ischemic Stroke Trial

The company was approved to commence a combined Phase I/II clinical trial to treat motor deficits due to ischemic stroke with its NSI-566 spinal cord stem cells at BaYi Brain Hospital, in Beijing, through its subsidiary, Neuralstem China 神脑生物医药公司 (Suzhou Neuralstem Biopharmaceutical Company, Ltd.). BaYi Brain Hospital prides itself on its world-class research facilities and is one of the premier neurological hospitals in China.

The Phase I / II ischemic stroke trial, which commenced in December 2013, is testing direct injections into the brain of NSI-566, the same cell product used in the Phase II ALS trial in the U.S.  Worldwide, the entire ischemic stroke trial protocol, as well as the medical care and treatment that patients receive, will be the equal of Neuralstem’s FDA-approved trials in the U.S.

The Neuralstem China Phase I/II ischemic stroke trial is designed to enroll up to 118 patients who have suffered an ischemic stroke with chronic residual motor disorder, four to 24 months post-stroke. The stem cell therapy involves a one-time treatment of intracerebral injections of Neuralstem’s NSI-566 neural stem cells into the stroke area using well-accepted stereotactic injection procedures.

The trial is conducted in two parts. The first part of the study, Phase I, is open-label and designed to enroll 18 patients in six ascending dosing cohorts of three patients each. Each of these will receive ascending doses of NSI-566 to determine the maximum safe dose. The maximum safe dose determined in the first phase will be used to evaluate efficacy in the second part of the study, a Phase II/Proof-of-Concept study. This phase will be a multi-site, randomized, controlled, single-blind study and enroll up to 100 randomized subjects. Fifty percent of the subjects will receive a one-time treatment with the cells and physical therapy, and the other 50 percent will receive only the physical therapy with no surgery. Outcome measures during the follow-up period in Phase II will be conducted in single-blinded manner.

The combined study, including patient monitoring and data collection, is expected to take approximately two years.

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Stroke - An estimated seven million people in the U.S. today have survived a stroke. In China alone it is estimated that over 1,750,000 people per year now survive a stroke. Ischemic stroke, the most common type of stroke, occurs as a result of an obstruction within a blood vessel supplying blood to the brain. It accounts for 87 percent of all stroke cases, according to the American Stroke Association. Stroke is the fourth-leading cause of death in America and a leading cause of adult disability, according to the National Stroke Association. Upwards of two-thirds of stroke survivors have some type of disability, according to the National Stroke Association. Post-stroke motor deficits include paralysis in arms and legs, and can be permanent.