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| Primary information |
|---|
| ID | 10732 |
| Therapeutic ID | Th1168 |
| Protein Name | Autologous cultured chondrocytes |
| Sequence | NA
|
| Molecular Weight | NA |
| Chemical Formula | NA |
| Isoelectric Point | NA |
| Hydrophobicity | NA |
| Melting point | NA |
| Half-life | NA |
| Description | Autologous cultured chondrocytes, the Carticel product, are derived from in vitro expansion of chondrocytes harvested from the patient's normal, femoral articular cartilage. Biopsies from a lesser-weight bearing area are the credit of chondrocytes, which are isolated, expanded through cell culture, and implanted into articular cartilage defects beneath an autologous periosteal flap. Prior to final packaging, cell viability is assessed to be at least 80%. |
| Indication/Disease | Is indicated for the repair of symptomatic cartilage defects of the femoral condyle (medial, lateral or trochlea), caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure (e.g., debridement, microfracture, drilling/abrasion arthroplasty, or osteochondral allograft/autograft). |
| Pharmacodynamics | Published data show that autologous chondrocyte implantation (ACI) is more likely than MST to result in hyaline-like cartilage at the repair site.1,2,4,5 However, because of differences in study design, lesion size and concomitant patient conditions, these data are not sufficient to draw conclusions concerning the long-term correlation of histology and clinical outcomes. |
| Mechanism of Action | Hyaline cartilage forms the articular surface of the femoral condyle. Studies have shown that implantation of autologous chondrocytes into the articular defect can result in the development of hyaline-like cartilage |
| Toxicity | Unwanted effects from therapy include arthrofibrosis/joint adhesions, graft overgrowth, chondromalacia or chondrosis, cartilage injury, graft complication, meniscal lesion and graft delamination in less than 5% of total patients who underwent treatment. |
| Metabolism | NA |
| Absorption | NA |
| NA |
| Clearance | NA |
| Categories | Autologous Cultured Cell |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | NA |
| Brand Name | Carticel |
| Company | Genzyme Corporation |
| Brand Description | Genzyme Corporation |
| Prescribed For | NA |
| Chemical Name | NA |
| Formulation | Strength: 12000000 1/1 |
| Physical Appearance | Implant |
| Route of Administration | Intra-auricular |
| Recommended Dosage | NA |
| Contraindication | Carticel should not be used in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides or materials of bovine origin. Gentamicin is added to both the cartilage biopsy transport media and in the culture media used during the processing of Carticel. Residual quantities of gentamicin up to 5 μg/mL are present in the Carticel product. Fetal bovine serum is a component in the culture medium used to propagate the autologous chondrocytes. Trace quantities of bovine-derived proteins may be present in the Carticel product. |
| Side Effects | The most common serious adverse events (> 5% of patients) derived from the STAR study include arthrofibrosis/ joint adhesion, graft overgrowth, chondromalacia or chondrosis, cartilage injury, graft complication, meniscal lesion and graft delamination. Only serious adverse events were collected in this study. |
| Useful Link 1 | Link |
| Useful Link 2 | NA |
| Remarks | NA |