Challenges in the clinical translation of stromal vascular fraction therapy in regenerative medicine

Table 2 Comparison of regulatory frameworks for stromal vascular fraction therapy

Regulatory agency	Classification of SVF	Key requirements for approval	Pathway to market
FDA (United States)	Biological product or medical device	Comprehensive preclinical and clinical data. GMP. Detailed characterization of SVF	Investigational New Drug application. Biologics license application or device approval
EMA (EU)	Advanced therapy medicinal product	Robust clinical trial data. Compliance with GMP. Safety and efficacy demonstration	Marketing authorization application. Scientific advice and protocol assistance
Health Canada	Biological drug	Evidence of safety, efficacy, and quality. Adherence to GMP	Clinical trial application. New drug submission
TGA (Australia)	Biological therapeutic	Demonstrated safety and efficacy. Quality manufacturing processes	TGA submission
PMDA (Japan)	Regenerative medicine product	Extensive clinical data. Compliance with good clinical practice	Clinical trial notification. Marketing authorization

SVF: Stromal vascular fraction; FDA: Food and Drug Administration; EMA: European Medicines Agency; EU: European Union; TGA: Therapeutic Goods Administration; PMDA: Pharmaceuticals and Medical Devices Agency; GMP: Good manufacturing practices.