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StemCells, Inc. CEO Discusses Interim 6-Month Data From Spinal Cord Injury Trial - Call Transcript

In that regard we examine the patients clinically for a number of sensory modalities in the thoracic area which include light touch, pinprick pain, and temperature sensation. We’re also doing tests to examine electrical impulse transmission in the spinal cord across the level of injury and this refers to what is known as somatosensory evoked potentials or SSEPs as well as electrical heat potentials, different sensory stimuli if you will that are then recorded to determine whether any electrical current across the level of injury. And then of course, MRI imaging as well.

The summary today that we’ll be providing you with in more detail that Dr. Curt will go through has given us so far a very favorable safety profile. At this point with the six month interim data we have no adverse events that are related to the cells and there’s no evidence of any change in the pain threshold or sensation for the patients in terms of adverse concerns. Also, the surgery immunosuppression have been well tolerated in all three patients.

As we have examined these patients over time at both the three and six month intervals, Dr. Curt and his team have observed considerable gains in sensory function in two of the three subjects. The third subject remains stable. What we have seen is changes in sensory modalities over more than one time of sensation and we see these in multiple segments below the level of injury. We’ve also been able to look at these sensory changes in a quantitative way as well as looking at electrophysiology and this is again, details that Dr. Curt will go into. But both the quantitative and electrophysiology are helping confirm the clinical examination changes that we are seeing for sensations in these two patients. So in general what we have seen no win this interim analysis is progressive and consistent changes in sensory function over more than one level in both of these patients and give what we understand to be the history of spinal cord injury recovery we think that these changes are unanticipated and we’ll show you some data from the European network that speaks to this in detail.

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