Humane allogene, uit de huid afkomstige ABCB5+ mesenchymale stromale cellen Medicine 04 December 2025 Extended indication Recessive Dystrophic Epidermolysis Bullosa (RDEB) and Junctional Epidermolysis Bullosa (JEB) in infants, toddlers over 6 months of age, children, adolescents, adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Humane allogene, uit de huid afkomstige ABCB5+ mesenchymale stromale cellen Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Skin diseases Extended indication Recessive Dystrophic Epidermolysis Bullosa (RDEB) and Junctional Epidermolysis Bullosa (JEB) in infants, toddlers over 6 months of age, children, adolescents, adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name APZ 2 Manufacturer RHEACELL Portfolio holder RHEACELL Mechanism of action Route of administration Intravenous Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks AOP Health is de commercialiseringspartner. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP Yes Submission date September 2026 Expected Registration October 2027 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fabrikant verwacht indiening bij de EMA in het derde kwartaal van 2026. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT05464381; NCT05838092 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks