The first patient was treated in the phase I/II NSI-566 stem cell trial to treat motor deficits from ischaemic stroke at BaYi Brain Hospital in Beijing, China, according to a press release
The patient received treatment on 27 December 2013. The trial is sponsored by Neuralstem China. The stroke motor deficit trial is the first in which Neuralstem’s spinal cord derived stem cells are being transplanted directly into the patient’s brain. They are placed near the stroke lesion, where it is hoped they will rebuild damaged neural circuitry and promote repair and recovery. The trial is expected to last two years.
“We are excited to begin the first trial where the route of administration for our cells is injection into the brain,” said Karl Johe, Neuralstem chairman and chief scientific officer. “We would like to thank our colleagues at BaYi, who are making this possible, and the patients who have volunteered for this ground-breaking trial. It is a crucial step forward for the company and the field at large, since optimising cell therapy treatment for central nervous system indications will require delivering cells to the brain, as well as to the spinal cord.”
“We are glad to be part of this world-leading clinical research project,” says Ruxiang Xu, chief physician, BaYi Brain Hospital.
“BaYi Brain is a leading neurological medical institution in China with a state-of-the-art facility and advanced medical research and care staff. Through international collaborations, such as the clinical trial of neural stem cells for the treatment of ischaemic stroke, we hope to be at the forefront of this new medical paradigm, treating multiple neurological diseases/disorders, such as ischaemic stroke, spinal cord injury, ALS, and others, using the most advanced neural stem cells, developed by our US partner, Neuralstem”.
The Neuralstem China phase I/II ischaemic stroke trial will enrol up to 118 patients who have suffered an ischaemic stroke and have chronic residual motor disorders, between four and 24 months after they have their strokes. The treatment will consist of one-time intracerebral injections of Neuralstem’s NSI-566 stem cells into the stroke area using well-accepted stereotactic injection procedures.
Phase I is expected to enrol up to 18 patients in three cohorts, each receiving an increasing dose, to determine the maximum safely-tolerated dose. Phase II, a multi-site, randomised and blinded study with a control group, is estimated to enrol up to 100 post-stroke patients. Half of these patients will receive a one-time treatment with the cells and physical therapy. The other half will receive only the physical therapy with no surgery. Measurements of outcome during the follow-up period will be blinded.