Shanghai-based Unixell Biotech’s iPSC-derived allogeneic cell therapy targeting focal epilepsy has secured Investigational New Drug (IND) clearance from the U.S. FDA, marking the first time the agency has allowed this type of cell therapy for epilepsy to be tested in humans.
In epilepsy patients, impaired GABAergic interneurons drive neural hyperexcitability and seizures. UX-GIP001 targets this by leveraging Unixell's proprietary stem cell technology to produce inhibitory neural progenitor cells through directed differentiation. After transplantation, it reconstructs inhibitory circuits, suppressing seizures.
Unixell’s preclinical studies have demonstrated the efficacy of UX-GIP001 in epileptic animal models and its safety profile, supporting progression to clinical trials. The phase 1 study will evaluate the safety, tolerability and efficacy of UX-GIP001 for drug-resistant epilepsy patients.
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