Active Ingredient: Autologous chondrocytes
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.
For this indication, competent medicine agencies globally authorize below treatments:
Intra-articular
10 - 70 {dose} per m² of body surface area (BSA)
From 10 To 70 {dose} per m² of body surface area (BSA) once every day
10-70 spheroids are applied per square centimetre defect
For intraarticular use.
Autologous chondrocytes αρε administered to patients by intraarticular implantation.
Patients treated with autologous chondrocytes have to undergo a specific rehabilitation program. The program may take up to one year depending on the recommendation of the physician.
Application in obese patients is not recommended.
The implantation must be performed during a surgical procedure (preferably an arthroscopy or miniarthrotomy). A debridement of the defect area is required. The subchondral plate should not be damaged. The spheroids are provided in a pre-filled syringe or an applicator (stem length 150 mm (co.fix 150)). Spheroids should be applied evenly on the defect ground and, if necessary, spread over the whole defect area by means of surgical instruments. The spheroids self-adhere within 20 minutes onto the defect ground. Afterwards, the surgical wound can be closed without any additional cover of the treated area (e.g. periosteal flap; matrix), or any fixation of spheroids by using fibrin glue. The treatment of defect sizes up to 10 cm² is eligible for single as well as adjacent defects (combined area).
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