Expand all sections

Autologous human chondrocytes in vitro expanded

NOVOCART 3D

Extended indication Treatment of localised, full-thickness cartilage defects of the knee joint caused by acute or repeti
Therapeutic value No estimate possible yet
Registration phase No registration expected

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
Route of administration Not applicable
Budgetting framework Intermural (MSZ)
Additional remarks NOVOCART 3D is a autologous chondrocyte implantation product, meaning that the patient's own cartilage is harvested and cultivated to produce the implant.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP Yes
Submission date August 2020
Orphan drug No
Registration phase No registration expected
Additional remarks De fabrikant heeft de indiening in december 2020 teruggetrokken vanwege aanvullende data die op het moment niet aangeleverd kon worden.

Therapeutic value

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

Expected patient volume per year

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.

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.