Single-center Phase 1 RCT assesses ALC05 injection safety in unilateral mesial temporal lobe epilepsy patients.
This single-center Phase 1 randomized controlled trial enrolled 12 patients diagnosed with unilateral mesial temporal lobe epilepsy. The primary objective was to assess the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) following a single intracranial injection of ALC05, which consists of iPSC-derived GABAergic interneurons. Patients were randomized into low-dose and high-dose groups to evaluate tolerability and safety. Secondary outcomes included cell engraftment, survival rates, responder rates, and seizure frequency.
The study design incorporated a one-year follow-up period within the initial study phase, with plans for a subsequent 15-year long-term safety follow-up after the initial period concludes. Specific numerical results regarding the incidence of adverse events, serious adverse events, discontinuations, or tolerability were not reported in the available data. Consequently, no quantitative data on safety signals or efficacy metrics could be extracted for this analysis.
Key limitations include the small sample size of 12 subjects and the lack of reported safety data, which precludes a robust assessment of the intervention's risk profile. Funding sources and potential conflicts of interest were not reported. Given the absence of reported adverse events or specific outcome numbers, the clinical relevance of these findings remains uncertain. Further investigation with larger cohorts and complete safety reporting is required before these results can inform clinical practice.
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