Extended indication Repair of symptomatic articular cartilage defects of the femoral condyle and the patella of the knee
Therapeutic value No estimate possible yet
Registration phase Positive CHMP opinion

Product

Active substance Spheroids of human autologous matrix-associated chondrocytes
Domain Metabolism and Endocrinology
Reason of inclusion Indication extension
Main indication Other metabolism and Endocrinology
Extended indication Repair of symptomatic articular cartilage defects of the femoral condyle and the patella of the knee (International Cartilage Regeneration & Joint Preservation Society [ICRS] grade III or IV) with defect sizes up to 10 cm2 in adults and adolescents with closed epiphyseal growth plate in the affected joint.
Proprietary name Spherox
Manufacturer Co.don AG
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
ATMP Yes
Submission date December 2020
Expected Registration July 2021
Orphan drug No
Registration phase Positive CHMP opinion
Additional comments Positieve CHMP-opinie in mei 2021.

Therapeutic value

Therapeutic value No estimate possible yet
References NCT01222559

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost 11,500.00
References Autologous chondrocyte implantation with Spherox for treating articular cartilage defects in the knee. (NICE ID 851) Warwick Evidence ERG report October 19th 2017
Additional comments In een rapport uit 2017 worden de kosten per patiënt geschat op £10.000.

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.