Nepla-tem-cel Medicine 04 June 2024 Extended indication Nepla-tem-cel (neuro-cells) monotherapy for treatment of (sub)acute traumatic Spinal cord injury in adults. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Nepla-tem-cel Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Neurological disorders other Extended indication Nepla-tem-cel (neuro-cells) monotherapy for treatment of (sub)acute traumatic Spinal cord injury in adults. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Neuroplast Portfolio holder Mechanism of action Gene therapy Route of administration Intrathecal Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Fabrikant: neuroplast Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Yes Submission date February 2025 Expected Registration March 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks 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 Additional remarks NCT03935724 Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks In Europa is de prevalentie van ruggenmergletsel 32 op de 100.000. 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks