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Framing efficacy through a systems lens, this review integrates three interlocking levers: (i) cell\u2010intrinsic programs (tissue imprint, transcriptional\/epigenetic state, senescence and metabolic fitness), (ii) microenvironmental constraints and designable cues, and (iii) pre\u2010 and post\u2010delivery engineering interventions. We highlight how spatially organized biofabrication\u2014especially 3D bioprinting that tunes geometry, stiffness, and factor presentation\u2014converts a simple cell infusion into an architected niche that stabilizes survival, aligns angiogenesis, and accelerates functional integration. We also synthesize optimization levers spanning biochemical\/cytokine licensing, hypoxic and mechanical conditioning, genetic\/epigenetic programming, and extracellular\u2010vesicle\u2013centered strategies; exemplar platforms show that 3D culture and printing can amplify small EV yield and pro\u2010regenerative content, translating to enhanced vascularization and repair in vivo. Translationally, early\u2010 and mid\u2010phase studies show adult stem cells \u2014particularly MSCs\u2014are broadly deliverable with acceptable safety; however, heterogeneity in sourcing, manufacture, dose\/route, endpoints, and follow\u2010up undermines comparability, meta\u2010analysis, and payer confidence. We outline a path toward adequately powered, multicenter randomized trials under harmonized controls and mechanism\u2010linked potency assays with standardized clinical and biomarker endpoints. Finally, we examine the regulatory architecture: divergent definitions (manipulation, homologous use), GMP\/GTP interpretations, and registry opacity enable uneven evidentiary thresholds and, at times, unregulated offerings\u2014conditions that demand convergence on technical standards, explicit oversight transparency, and risk\u2010based enforcement. Throughout, mesenchymal stem\/stromal cells (MSCs) serve as the principal exemplar of adult stem cells, with other adult stem cell populations cited to show that these principles generalize across cell types.<\/jats:p>","DOI":"10.1002\/advs.76207","type":"journal-article","created":{"date-parts":[[2026,6,19]],"date-time":"2026-06-19T09:04:44Z","timestamp":1781859884000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Beyond Potency: Emerging Determinants and Optimization Strategies Enhancing Therapeutic Efficacy of Adult Stem Cells"],"prefix":"10.1002","volume":"13","author":[{"given":"Soo\u2010Rim","family":"Kim","sequence":"first","affiliation":[{"name":"Department of Health Sciences and Technology GAIHST Gachon University  Incheon Republic of Korea"},{"name":"Department of Molecular Medicine School of Medicine Gachon University  Incheon Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yun Jae","family":"Jung","sequence":"additional","affiliation":[{"name":"Department of Health Sciences and Technology GAIHST Gachon University  Incheon Republic of Korea"},{"name":"Department of Microbiology College of Medicine Gachon University  Incheon Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1958-8548","authenticated-orcid":false,"given":"Hwa\u2010Yong","family":"Lee","sequence":"additional","affiliation":[{"name":"Division of Science Education Kangwon National University  Chuncheon Republic of 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