The idea that we could treat traumatic brain injury, stroke, brain hemorrhage, and then, further afield, spinal cord injury, Parkinson disease, Alzheimer disease, amyotrophic lateral sclerosis, perhaps. The whole concept of regenerative medicine is getting better and growing. This type of approach has gained a lot of traction in medicine in recent years, so what does this represent for you in terms of the advances that have been made in TBI care? Yes, it's a very hard science, but there's a real emotional aspect to it that I just found very exciting. I mean, this isn't the typical hard science that we talk about. We had a patient who never spoke a word-he was aphasic after his traumatic brain injury-say his first words with my occupational therapist researcher, myself, and his mom in the room, and his mom burst out in tears. As a clinician and researcher with multiple patients at our center, I got to see things like people being able to use their hand that they couldn’t use. Their lives, in an instant, were taken away from them. But we had some as young as 18 years old. The average age of the participants in the trial was 34 years. Over the years, I've given many talks at conferences at AAN and other conferences like it. What has been the reaction from the clinical community to these data? Now, going forward, we're going to work on a larger, double-blind, randomized, sham-controlled study using just that 5 million stem cell dose versus a sham. Patients did considerably better in 5 than 2.5 or 10. We also figured out among the 2.5, 5, and 10 million stem cell doses, the 5 million was the sweet spot. The clinician and the individual patient could tell whether they were on placebo or not. So here, in a phase 2 trial-it was only 61 patients, so there are further data to be collected, but-everything including dexterity, disability, motor, sensory, gait speed improved, everything. We can give a little botulinum neurotoxin to help with spasticity, but we've never improved function with that. There are no treatments at all right now. Moderate or severe traumatic brain injury is devastating to the individual, to the families, and even to society from a cost of care basis. Having been a clinical researcher for nearly 25 years, this is one of the most exciting trials I've ever done. For you, what’s the major takeaway from these data? That is, compared to the sham group, the people who got the stem cells did statistically significantly better on the Fugl-Meyer Motor Index. The primary outcome measure was met at week 24. That included quality of life, sensory measures, and employability-we just ran the gamut. The primary outcome measure was the Fugl-Meyer Motor Index-that's looking at passive and active range of motion, upper and lower extremity, some dexterity, etc-and we had a whole host of other secondary end points as well. We looked at the 3 different doses versus the sham, and a number of different measures. There was another group, the sham group, that we drilled halfway down the skull, and then we came out. Then, we drilled a hole in their head with a 2 mm burr hole through the skull, and stereotactically infused either 2.55 or 10 million adult mesenchymal stem cells. McAllister, MD, FAAN: We took 61 adults who had a moderate or severe traumatic brain injury, did an MRI, and saw an area of encephalomalacia. NeurologyLive ®: Could you provide an overview of your presentation of the STEMTRA data? While on-site, he sat down with NeurologyLive ® at AAN to discuss these data and their implications for the clinical community. McAllister, MD, FAAN, board-certified neurologist, and medical director and chief medical officer, New England Center for Neurology and Headache, presented the data at AAN 2022. Those who received the treatment experienced significant improvements in motor function measured by Fugl-Meyer Motor Scale scores (SB623: 8.3 points sham: 2.3 points P =. The primary end point was met, showing a trend toward the maintenance of functional and activities of daily living improvements in 1-year analysis. The trial included 61 patients, of whom 46 were treated and 15 underwent sham surgery. Overall, STEMTRA assessed the efficacy and safety of SB623 compared with sham surgery in individuals with chronic motor deficits from TBI. At the 2022 American Academy of Neurology (AAN) Annual Meeting, April 2-7, in Seattle, Washington, new data from the phase 2 STEMTRA trial (NCT02416492) were presented, demonstrating that SB623, an investigational allogeneic bone marrow-derived modified mesenchymal stem cell therapy developed by SanBio, has potential in treating individuals with traumatic brain injury (TBI).
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