European Regulation (EC) No 1394/2007 created a new class of drugs in 2007 called : “Advanced Therapy Medicinal Products”, resulting from cellular and tissue engineering, genetic manipulation, and possibly combined with medical devices. More than fifteen years after the implementation of this regulation, the results remain mixed in the development of these new therapies while somatic cell therapy approaches remain limited with complex medico-economic models given the benefit provided to the patient with regard to already existing treatments. This situation led to the question to reconsider hospital exemption (HE) as an opportunity to develop ATMPs in close contact with clinical practice, with the quality and rapid access needed by patients and at a lower cost compared to regular market authorization. This communication summarize this possibility taking as example the development of autologous stromal vascular fraction for patients presenting fistulas in the context of Crohn’s disease and developed by Marseille University hospital (France).   Jérémy Magalon obtained his PharmD at the University of Aix-Marseille in 2013 after completing a pharmacy internship in medical biology and a specialization in cell therapy. He holds a university degree in regenerative medicine and a master's degree in tissue, cellular and genetic biology. During his residency, he worked on HLA diversity of placental blood banks, therapeutic use of platelet concentrates in regenerative medicine and his other areas of expertise are autologous stromal vascular fraction derived from adipose tissue and adipose tissue grafting.  In 2014, he became  hospital practitioner at the Necker Hospital (Paris) in the biotherapy department where he participated in the implementation of pioneering clinical trials using gene therapy to treat patients with severe hemoglobinopaties. He obtained his PhD in 2018, with a manuscript entitled "Development of an innovative therapeutic drug using the stromal vascular fraction of autologous adipose tissue in systemic sclerosis: From biological characterization to the identification of potential biomarkers of efficacy". He is currently Assistant Professor at the University of Aix-Marseille (Faculty of Pharmacy) and at the University Hospital of La Conception (Cell Therapy Department). He is the author of over 80 Pubmed-indexed articles and 5 book chapters on the subject of regenerative medicine, and has been a speaker at over 30 national and international conferences. He recently co-founded the start-up Remedex, which aims to offer to independent doctors a pharmaceutical supervision for the realization of local regenerative medicine procedures.    

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