dm+d

Unassigned

New Medicines

SpheroxRepair of symptomatic articular cartilage defects of the femoral condyle and the patella of the knee in adolescents with closed epiphyseal growth plate in the affected joint

Information

Spherox
New formulation
CO.DON AG
Not Known

Development and Regulatory status

None
Launched
None
Jun 21Licence change approved in EU [2].
May 21Recommended for approval in EU. The new indication is for 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. Previously only licensed for use in adults [1].

Category

Spherical aggregates of chondrocytes. In this therapy, a small piece of cartilage is excised from the healthy cartilage and chrondrocyte spheroids are produced in a laboratory. These spheroids are then inserted arthroscopically in the patient knee.
Damage to the articular cartilage of the knee is a common orthopaedic problem which often occurs in young, active people. It can result from direct trauma, repetitive injuries, fractures, or degenerative and inflammatory conditions. People with this type of damage experience recurrent pain and swelling of the joint, locking of the knee and may be impaired in their ability to walk or participate in sports. To restore functionality of their knee, patients often opt for surgery [2].
Repair of symptomatic articular cartilage defects of the femoral condyle and the patella of the knee in adolescents with closed epiphyseal growth plate in the affected joint
Intraarticular

Evidence based evaluations