FDA clears expansion of stem cell clinical trials for SCI

The Food & Drug Administration gave Asterias Biotherapeutics the green light last week to expand the number and type of people with spinal cord injuries that it treats in their stem cell clinical trials.

In its most recent round of trials, Asterias was only allowed to enroll individuals with C5-C7 level injuries.  Now, they will be able to treat people with injuries at the C4 level, that’s not only higher up the neck but it’s also the second most common form of spinal cord injury.  Caring for someone with a C4 injury is expensive, with lifetime costs estimated around $5 million.

Asterias is not only expanding the patient population they are working with, they are also expanding the window for treating the injury.  Currently, patients have to be enrolled from 14 to 30 days post injury. In this new C4 group, that window has been extended to 21 to 42 days post injury.  The reason for that change is that because C4 is higher up in the neck, newly injured people often need to be placed on a ventilator to help stabilize them. These patients take a little more time to recover from the initial trauma before they are ready to be treated.

Additionally, the company is already treating some trial participants with an injection of 20 million cells to the site of the injury (from the initial round of 10 million) and hopes to start enrolling additional individuals in the increased dose later this summer.