KUALA LUMPUR, April 11 (Bernama) -- Neuralstem Inc has completed the first surgery in the second, cervical injury cohort of a Phase one clinical trial in patients with chronic spinal cord injury (cSCI).
The company conducted a Phase one human clinical trial evaluating the safety and feasibility of using NSI-566 spinal cord-derived neural stem cells to repair cSCI. NSI-566 is Neuralstem's lead stem cell therapy candidate, a statement said.
The trial was conducted at the University of California San Diego (UCSD), Division of Neurosurgery and it was expanded to include a new cohort of four qualifying patients in April 2017 with AIS-A complete, quadriplegic, cervical injuries involving C5-C7 of their spinal cord, after promising results were observed with the first cohort.
The trial also evaluated the safety and feasibility of using NSI-566 spinal cord-derived neural stem cells to repair cSCI.
The amended protocol was approved by the U.S. Food and Drug Administration and the Institutional Review Board at the study site, UCSD and can be found on clinicaltrials.gov (NCT01772810). The first surgery for the second cohort was completed on March 28.
"This study involves complete injury patients with no motor or sensory function below injury. The first four paraplegic cases with thoracic injury went exceptionally well. We are excited to move forward with the next four quadriplegic cases with cervical injury," said chief scientific officer Neuralstem, Karl Johe Ph.D.
Neuralstem Inc is a clinical-stage biopharmaceutical company developing novel treatments for nervous system diseases of high unmet medical need and focused on the development of nervous system therapies based on its neural stem cell technology.
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