ArticleRegenerative therapy2026
Development of an effective direct qPCR method for cell therapy product quantification in non-clinical biodistribution studies.
Article in Regenerative therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Evaluating the non-clinical biodistribution (BD) of cell therapy products (CTPs) is essential to predicting their efficacy and safety in clinical trials. Although BD is typically quantified by qPCR following DNA extraction, this process is labor-intensive and time-consuming, and subject to variability in extraction yield, which complicates normalization to organ weight or blood volume. In contrast, direct qPCR enables the quantification of lysed samples without DNA extraction. Here, we systematically developed an effective direct qPCR method applicable to BD studies of CTPs. Methods: We used HLCN061, a genetically modified natural killer (NK) cell derived from human induced pluripotent stem (iPS) cells. Mouse organs and blood containing HLCN061 cells were lysed, diluted, and directly subjected to real-time PCR using a human-specific Alu primer set. PCR reactions employed an inhibitor-tolerant master mix. Assay performance was evaluated by linearity (R Results: Across all tissues and blood samples, R Conclusion: This direct qPCR method is effective and suitable for non-clinical BD assessment of CTPs.
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