TB-402 / Y's Therapeutics - LARVOL DELTA

Autologous Stem Cells from Human Exfoliated Deciduous Teeth (SHED) in Children with Cerebral Palsy: A First-in-Human Phase I Trial (Interim Analysis) (PAS 2026) - "Preclinical studies demonstrate their strong neurogenic and neuroprotective potential via paracrine mechanisms, improving motor function in chronic-phase CP models and showing superior neurogenic effects compared to other mesenchymal stromal cells.Objective: This first-in-human, open-label Phase I clinical trial registered with jRCTb040230042, aimed to evaluate the safety, tolerability, feasibility, and preliminary efficacy of intravenous administration of autologous SHED in children with CP... All three patients completed the SHED infusion without any acute infusion-related adverse reactions. No serious adverse events related to SHED administration were observed during the 4-week follow-up period. At 12 weeks post-infusion, GMFM-66 scores improved in all patients, with an average increase of 3.2 points, exceeding the minimal clinically important difference."

Clinical • First-in-human • P1 data • Cerebral Palsy • CNS Disorders