Stephen Huhn, M.D., FACS, FAAP
This morning we have about 20 or 21 Slides to go through and as Martin said I’ll have some brief remarks in the first few slides and then I’m going to have Dr. Curt go through the interim data in more detail and then we’ll finish up with a Q&A at the end. The Phase I/II study design, just to remind everyone is an open label clinical investigation dealing with a single dose and a fixed dose of the human central nervous system stem cell which is delivered directly into the spinal cord at a dose of 20 million cells.
Patients are immuno suppressed because this is an alginate transplant for a period of nine months post operatively. The trial is designed to enroll 12 subjects who have a thoracic level injury from the second thoracic segment down to the 11 th segment. Patients are eligible to enroll in this trial who are between three and 12 months after injury and this corresponds to what we believe is generally considered the sub acute or late sub acute to early chronic phase of spinal cord injury.
In addition to the timeframe after injury patients who both have a complete and incomplete type of injury are eligible for the trial and will be enrolled in a sequential fashion. The first cohort of the trial, the subject of our discussion today, are those patients who have complete injury and by that I mean patients who have lost sensory function and motor function below the level of spinal cord trauma. This of course corresponds with what we call the AIS cohort A.The trial will then continue after we dose this first cohort into patients with incomplete injury AISA B and ASIA C patients. With each cohort we have a data monitoring committee that will review the status of not only the recent safety data but the equivalent safety data from the prior dosed patients as we continue in the trial. The trial is first and foremost designed to examine safety, tolerability, and feasibility of our interventions but we’re also obviously expanding a lot of effort to determine whether we have any signals of an effectiveness.
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