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This investigational cell therapy consists of allogeneic human umbilical cord-derived mesenchymal stem cells (UC-MSCs) developed by Translational Biosciences, a division of MediStem Panama, for the treatment of autism spectrum disorder (ASD). The therapy is designed to address immune dysregulation and neuroinflammation, which are hypothesized to contribute to the pathophysiology of ASD. The biological mechanism involves the modulation of the immune system and the reduction of inflammatory cytokines, specifically targeting macrophage-derived chemokine (MDC) and thymus and activation-regulated chemokine (TARC). In a Phase I/II clinical trial (NCT02192749), the cells were administered intravenously to children aged 6-16. While the study initially suggested the treatment was safe, the published results were later retracted, casting doubt on the reported efficacy and safety profile.
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