STEM CELL-BASED REGENERATIVE THERAPIES: FROM BENCH TO BEDSIDE

Abstract

Stem cell–based interventions are maturing from experimental paradigms to regulated clinical products across hematology, ophthalmology, dermatology, and orthopedics. This review synthesizes biological foundations, translational workflows, manufacturing and quality requirements, and the clinical evidence base, emphasizing pluripotent (ESC/iPSC) and adult (HSC/MSC) cell platforms. We analyze delivery routes, potency assays, biodistribution, and safety signals (tumorigenicity, immune activation, arrhythmia), and outline regulatory pathways including accelerated designations for regenerative medicines. Case studies—gene-modified hematopoietic stem cells for inherited disorders, retinal pigment epithelium grafts for macular disease, engineered epidermis for genodermatoses, and mesenchymal stromal cells for musculoskeletal indications—illustrate the bench-to-bedside arc. Finally, we propose a pragmatic roadmap for scalable, equitable deployment, with attention to ethics and access in low- and middle-income settings.