Washington University School of Medicine new spinal cord injury clinical trial site: 7 takeaways

Mackenzie Garrity -  

The St. Louis-based Washington University School of Medicine is a new clinical study site for Asterias Biotherapeuturics SCiStar clinical trial of AST-OPC1 stem cells in patients with severe cervical spinal cord injuries.

Here are seven takeaways:


1. Patients participating in the trial are categorized into:


• AIS-A patients: those who have lost all motor and sensory functions below their injury sites.

• AIS-B patients: those who have lost all motor function but have minimal sensory function below their injury site.


2. The stem cells are administered 21 to 42 days post injury and patients are followed by neurological exams and imaging procedures to asses the progress and safety of the trial.


3. W. Zachary Ray, MD, a neurological and orthopedic surgery associate professor at Washington School of Medicine, will lead the site's investigation.


4. Asterias Biotherapeuturics receive FDA clearance to progress its clinical study after phase one of the trial showed five patients with neurologically complete thoracic spinal cord injuries improved motor function after being administered 2 million AST-OPC1 cells.


5. The California Institute for Regenerative Medicine granted Asterias Biotherapeuturics $14.3 million in funding for the clinical trial and other product development activities for AST-OPC1.


6. There are now nine centers across the U.S. participating in the clinical trial.


7. Asterias Biotherapeuturics is a biotechnology company focuses on developing regenerative medicine.


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