Spheroids of human autologous matrix-associated chondrocytes
Regulatory sources consulted
- EMA EPAR EMEA/H/C/002736
- EMA SmPC Spherox (ES)
- EMA SmPC Spherox (EN)
- EMA SmPC Spherox (FR)
- EMA EPAR · EMEA/H/C/002736 ↗
Approved indications
- Repair of symptomatic articular cartilage defects of the femoral condyle and the patella of the knee (International Cartilage Repair Society [ICRS] grade III or IV) with defect sizes up to 10 cm² in adults.
Contraindications
Absolute
- Hypersensitivity to the active substance, excipients, gentamicin (possible residue) or to bovine serum.
- Concomitant inflammatory arthritis or severe osteoarthritis (Kellgren and Lawrence grade > 1) in the knee joint compartment to be treated.
- Patients who are unable to follow the recommended rehabilitation regimen.
Clinical warnings
- Major warning · Traceability: The name of the product, the batch number and the name of the treated patient must be kept for a period of 30 years. — EMA
- The safety and efficacy in children and adolescents aged 0 to 18 years have not yet been established. — EMA
Drug interactions
- ModerateIntra-articular corticosteroidsH02AB
Mechanism: Potential negative effect on the viability and function of the implanted chondrocytes.
Recommendation: Avoid intra-articular injections into the treated knee post-operatively.
EMA SPC
Adverse events
Common (≥1%)
arthralgia · joint effusion · joint swelling · joint locking · incision site pain · crepitation · pain in extremity
Rare but serious
cartilage hypertrophy · deep vein thrombosis
Pregnancy and lactation
Not recommended during pregnancy or in women of childbearing potential not using contraception. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy.