Wednesday, 17 April 2013

Neuralstem to begin Phase II stem cell trial on amytrophic lateral sclerosis patients

Neuralstem just issued a press release saying it has received approval from the FDA to begin phase II clinical trials using its proprietary stem cell therapy, NSI-566, on patients with amyotrophic lateral sclerosis.

The trial will take place in the following centres:
  • Emory University Hospital in Atlanta, Georgia
  • ALS Clinic at the University of Michigan Health System, Michigan
During the trial, a total of 15 patients are expected to enroll, in five different dosing cohorts with the patients receiving injections containing the NSI-566 human spinal cord stem cells. The first twelve will receive stem cells only in the cervical region and the other three will receive both cervical and lumbar injections.

All participants must reside in close proximity to the research center they wish to participate.

Regarding the Phase I trial, Karl Johe, Chairman and Chief Scientific Officer of Neuralstem, said:

"As a result of the excellent safety and tolerability demonstrated in Phase I, we will be able to proceed more aggressively in Phase II. In Phase I, we started with just five injection sites per patient, and advanced to a maximum of 15 injections of 100,000 cells each. In Phase II, we will advance up to a maximum of 40 injections, and 400,000 cells per injection based on safety."

Johe says their goal now is to define what the maximum, optimal dosage is.

You can read the official press release here

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