Advanced Analytical Strategies and New Approach Methodologies for Regenerative Cell Therapies: Biomarkers, Critical Quality Attributes, and Translational Quality Assessment

Regenerative cell therapies offer major potential for restoring tissue function in musculoskeletal, craniofacial, inflammatory, and degenerative disorders. However, their translation remains limited by donor variability, biological heterogeneity, culture-induced changes, and the lack of robust measures that reliably predict therapeutic performance. In tissue engineering and regenerative medicine, these challenges make advanced analytical characterization especially important. Potency assays, biomarker-based evaluation, and emerging analytical tools are increasingly needed to assess critical quality attributes such as identity, functionality, consistency, and stability in cell-based regenerative products.This Research Topic focuses on advanced analytical strategies and new approach methodologies (NAMs) that improve the evaluation of regenerative cell therapies within tissue engineering and regenerative medicine. In this context, NAMs may include human-relevant in vitro systems, mechanism-informed functional assays, biomarker-based approaches, biosensor-enabled measurements, imaging-supported analytical platforms, multi-omics methods, and computational tools that strengthen product characterization and translational assessment. Particular emphasis will be placed on methods that help define, measure, or monitor critical quality attributes relevant to tissue repair and regeneration. Studies may address potency assays for stem, stromal, or progenitor cell products; biomarker discovery and qualification; comparability assessment; donor heterogeneity; culture effects on regenerative function; and analytical methods for secretome- or extracellular vesicle-associated activity where these are clearly linked to regenerative applications. The Topic aims to connect analytical innovation with practical relevance in regenerative medicine product development, process optimisation, and translational readiness.We welcome Original Research, Review, Mini Review, Methods, and Perspective articles on analytical strategies and NAMs for regenerative cell therapies in tissue engineering and regenerative medicine. Submissions may focus on mesenchymal stromal cells, stem/progenitor cell-based products, osteogenic or chondrogenic applications, wound healing, craniofacial repair, musculoskeletal regeneration, secretome-associated approaches, and related translational models. Manuscripts should clearly demonstrate relevance to regenerative medicine product development, product characterization, potency assessment, or translational quality evaluation. Purely clinical studies, purely regulatory commentaries, and general methodological papers without a clear connection to regenerative cell therapies for tissue repair and regeneration are outside the intended scope of this collection. Topic editors: Jorge Sans Burns, Guido Moll, Raghavan Chinnadurai Source: https://www.frontiersin.org/research-topics/81392/advanced-analytical-strategies-and-new-approach-methodologies-for-regenerative-cell-therapies-biomarkers-critical-quality-attributes-and-translational-quality-assessment