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MUSCULO-SKELETAL SYSTEM › OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM › OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM › Other drugs for disorders of the musculo-skeletal system
chondrocytes, autologous
M09AX02
Forms & Strengths
- Autologous cultured chondrocytes suspended in liquid medium
- Patient-specific implantation dosage (typically 10 to 30 million cells)
- Provided in a syringe or vial for arthroscopic or open surgical delivery
Adult Dosing
- Cartilage repair (knee): Matrix-induced autologous chondrocyte implantation (MACI) or autologous chondrocyte implantation (ACI)
- Dose determined by surface area of the articular cartilage defect, typically 1 million cells per cm2 of defect area
- Requires a two-stage procedure: initial arthroscopic biopsy of healthy cartilage followed weeks later by surgical implantation of cultured cells
Pediatric Dosing
- Safety and efficacy not established in pediatric patients with open epiphyses
- Use in adolescents is restricted and determined on a specialized, case-by-case basis by orthopedic surgeons
Indications
- Repair of symptomatic, full-thickness cartilage defects of the knee (femoral condyle, trochlea)
- Management of localized post-traumatic or degenerative cartilage lesions in carefully selected patients
Mechanism of Action
- Living autologous chondrocytes are introduced into the cartilage defect site to synthesize new extracellular matrix
- Produces type II collagen and aggrecan, promoting the regeneration of hyaline-like cartilage tissue
Contraindications
- Severe osteoarthritis of the knee joint
- General knee joint inflammatory conditions or active joint infection
- Known hypersensitivity to gentamicin, other aminoglycosides, or bovine-derived materials used in the culture process
- Patients unable to comply with the rigorous post-operative rehabilitation protocol
Adverse Reactions
- Procedural complications including arthralgia, joint swelling, and joint effusion
- Cartilage hypertrophy, delamination, or graft failure
- Procedural site infection and stiffness requiring arthroscopic lysis of adhesions
- Back pain and limb discomfort secondary to post-operative immobilization and physical therapy
Drug Interactions
- No formal drug-drug interaction studies have been performed due to the autologous cellular nature of the product
- Intra-articular administration of local anesthetics or corticosteroids immediately post-implantation may exhibit cellular toxicity and should be avoided
Curated Content: Needs Vetting Before Put to Clinical Use