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Nepla-tem-cel

Extended indication Nepla-tem-cel (neuro-cells) monotherapy for treatment of (sub)acute traumatic Spinal cord injury in
Therapeutic value No estimate possible yet
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.
Manufacturer Neuroplast
Mechanism of action Gene therapy
Route of administration Intrathecal
Budgetting framework Intermural (MSZ)
Additional remarks Fabrikant: neuroplast

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP Yes
Submission date February 2025
Expected Registration March 2026
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet
Additional remarks NCT03935724

Expected patient volume per year

Additional remarks In Europa is de prevalentie van ruggenmergletsel 32 op de 100.000.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.