Dr. Eva Feldman to present new data on ALS trial
Dr. Eva Feldman, director of the Taubman Institute, will present new data Oct. 8 on the Phase I trial she leads that involves implanting stem cells into the spinal cords of patients with ALS.
Dr. Feldman will present the interim data in her role as president of the American Neurological Association (ANA) at the ANA's annual conference in Boston.
The Phase I trial, being conducted in conjunction with Emory University and the biomedical firm Neuralstem, was designed to assess the safety of spinal cord neural stem cells and the intraspinal transplantation method in ALS patients. It commenced in January 2010, and consisted of 18 treatments in 15 patients. The trial was designed to follow a risk escalation paradigm. The first 12 patients were each transplanted in the lumbar (lower back) region of the spine, beginning with non-ambulatory and advancing to ambulatory cohorts.
The trial then advanced to transplantation in the cervical (upper) region of the spine. The first cohort of three was treated in the cervical region only. In an amendment to the trial design, The Food and Drug Administration (FDA) approved the return of previously-treated patients to this cohort. Consequently, the last cohort of three patients received injections in the cervical region in addition to the lumbar injections they had received earlier. All injections delivered 100,000 cells, for a dosing range of up to 1.5 million cells. The last patient was treated in August, 2012. None of the patients have suffered significant adverse effects as a result of the stem cell implantation.
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