Shanghai Unixell Biotechnology secured FDA IND clearance to test UX-GIP001, an allogeneic iPSC-derived cell therapy for focal epilepsy, the company reported. The Phase I study will evaluate safety and feasibility in patients with drug-resistant focal epilepsy, marking a rare U.S. IND for an iPSC-derived neurological cell product. Unixell plans to initiate clinical operations under the IND, which opens the pathway to human dose escalation and translational data for cell-based approaches to refractory epilepsy.
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