Autologous human chondrocytes in vitro expanded

Extended indication	Treatment of localised, full-thickness cartilage defects of the knee joint caused by acute or repetitive trauma or as a result of osteochondritis dissecans.
Therapeutic value	No judgement
Registration phase	Registration application pending

Product

Active substance	Autologous human chondrocytes in vitro expanded
Domain	Metabolism and Endocrinology
Reason of inclusion	New medicine (specialité)
Main indication	Other metabolism and Endocrinology
Extended indication	Treatment of localised, full-thickness cartilage defects of the knee joint caused by acute or repetitive trauma or as a result of osteochondritis dissecans.
Proprietary name	NOVOCART 3D
Manufacturer	TETEC
Budgetting framework	Intermural (MSZ)
Additional remarks	ATMP

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	Yes
Submission date	August 2020
Expected Registration	September 2021
Registration phase	Registration application pending

Current treatment options	Andere autologe kraakbeencelimplantaties of microfractuurbehandeling (MF)
Therapeutic value	No judgement
References	NCT01957722; NCT01656902

References	Autologe kraakbeencelimplantatie bij een kraakbeendefect in het kniegewricht: innovatieve DBC
Additional remarks	De prevalentie van hyalinekraakbeendefecten aan de knie is niet bekend, mede vanwege vele verschillende oorzaken. De incidentie ligt rondom de 2,6 patiënten per 1.000 volwassenen. Dit betekent dat er jaarlijks 44.200 patiënten in Nederland deze klachten hebben. Een deel hiervan zal mogelijk in aanmerking komen voor deze behandeling.

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.