Safety profile of autologous adipose-derived stromal vascular fraction in clinical use: an exhaustive literature review

Adipose tissue-derived stromal vascular fraction (SVF) has rapidly emerged as a promising tool in regenerative medicine due to its accessibility, autologous origin, and potent reparative potential. However, despite encouraging preclinical outcomes, the clinical safety of SVF across organ systems remains insufficiently characterized. This comprehensive review synthesizes current evidence on the safety and tolerability of autologous SVF therapy in humans, organized by target organ systems including cardiovascular, pulmonary, hepatic, renal, musculoskeletal, cutaneous, neurological, and inflammatory applications. Across studies, SVF therapy appears technically feasible and generally well tolerated, with adverse events predominantly mild and procedure-related (e.g., transient pain, swelling, or local inflammation). Serious complications - including embolism, infection, fibrosis, or tumor formation - have not been reported to date in clinical settings. However, available studies suffer from major limitations: small and heterogeneous cohorts, non-randomized designs, variability in cell preparation and dosing, and short follow-up durations. The lack of standardized isolation protocols and absence of mechanistic endpoints further restrict interpretation. Overall, current data support the short-term safety of autologous SVF therapy, while underscoring the need for large-scale randomized controlled trials, harmonized methodologies, and long-term surveillance to fully establish its risk-benefit profile.