The medical director and chief medical officer of the New England Center for Neurology and Headache spoke to the phase 2 STEMTRA trial results of the stem cell treatment SB623. [WATCH TIME: 4 minutes]
WATCH TIME: 4 minutes
“Having been a clinical researcher for nearly 25 years, this is one of the most exciting trials I’ve ever done. Moderate to severe traumatic brain injury is devastating—to the individual, to the families, and even to society from a cost of care basis. There are no treatments at all right now.”
New data from the phase 2 STEMTRA trial (NCT02416492) suggest that SanBio’s investigational allogeneic bone marrow-derived modified mesenchymal stem cell therapy, SB623, met the primary end point, showing a trend toward the maintenance of functional and activities of daily living improvements in 1-year analysis. STEMTRA assessed the efficacy and safety of SB623 compared with sham surgery in individuals with chronic motor deficits from traumatic brain injury (TBI).
Investigator Peter J. McAllister, MD, FAAN, board-certified neurologist, and medical director and chief medical officer, New England Center for Neurology and Headache, who presented at the 2022 American Academy of Neurology (AAN) Annual Meeting, April 2-7, in Seattle, Washington, sat down with NeurologyLive® at AAN to discuss these data. The trial included 61 patients, of whom 46 were treated and 15 underwent sham surgery. All told, those who received the treatment experienced significant improvements in motor function measured by Fugl-Meyer Motor Scale scores (SB623: 8.3 points [SD, 1.4]; Sham: 2.3 points [SD, 2.5]; P = .04).
McAllister shared his insight into the data and spoke about the importance of these results in TBI, which is complex to manage and has, to date, not seen an approved or effective treatment to address the complications of the condition. Additionally, he shared his perspective on the reaction to the data, which he described as “palpable.”