2026-08-04
Leaving Stem Cells Behind in the Chronic Stroke Brain — SB623, Two-Year Results in 18 Patients, and the Reckoning That Came Afterward
An average of 22 months after stroke, paralysis that should no longer move. A phase 1/2a trial implanting genetically modified allogeneic bone marrow MSCs (SB623) around the infarct met its primary endpoint in 18 patients over two years. But there is no control group. Two months later the phase 2b ACTIsSIMA, sham-controlled in 163 patients, missed its primary endpoint (p = 0.6743). The same cells reached approval not in stroke but in the parallel traumatic brain injury trial.
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