United States - English - NLM (National Library of Medicine)

vericel corporation - autologous cultured chondrocytes (unii: d5p3k3v822) (autologous cultured chondrocytes - unii:d5p3k3v822) - autologous cultured chondrocytes 1.2e+007 - carticel® 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). carticel should be used only in conjunction with debridement, placement of a periosteal flap and rehabilitation. the independent contributions of the autologous cultured chondrocytes and other components of the therapy to outcome are unknown. carticel is not indicated for the treatment of cartilage damage associated with generalized osteoarthritis. carticel is not recommended for patients with total meniscectomy unless surgically reconstructed prior to or concurrent with carticel implantation. carticel should not be used in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides or materials of bovine origin.

United States - English - NLM (National Library of Medicine)

vericel corporation - autologous cultured chondrocytes (unii: d5p3k3v822) (autologous cultured chondrocytes - unii:d5p3k3v822), pork collagen (unii: i8442u2g7j) (pork collagen - unii:i8442u2g7j) - autologous cultured chondrocytes 15000000 - maci® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the knee with or without bone involvement in adults. limitations of use - effectiveness of maci in joints other than the knee has not been established. - safety and effectiveness of maci in patients over the age of 55 years have not been established. maci is contraindicated in patients with the following conditions: - known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin. [see description (11)] - severe osteoarthritis of the knee (kellgren-lawrence grade 3 or 4). - inflammatory arthritis, inflammatory joint disease, or uncorrected congenital blood coagulation disorders. - prior knee surgery (6 months), excluding surgery to procure a biopsy or a concomitant procedure to prepare the knee for a maci implant. - inability to cooperate with a physician-prescribed post-surgical rehabilitation program [see dosage and administration (2.3)]. risk summary maci implantation requires invasive surgical procedures; therefore use during pregnancy is not recommended. limited clinical data on patients exposed to maci during pregnancy are available. there are insufficient data with maci use in pregnant women to inform a product-associated risk. animal reproduction studies have not been conducted with maci. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there is no information regarding the presence of maci in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for maci and any potential adverse effects on the breastfed infant from maci or from the underlying maternal condition. the safety and effectiveness of maci in pediatric patients have not been established. the safety and effectiveness of maci in patients over 65 years of age have not been established. clinical trials of maci did not include subjects over the age of 55.

United States - English - NLM (National Library of Medicine)

genzyme corporation - autologous cultured chondrocytes (unii: d5p3k3v822) (autologous cultured chondrocytes - unii:d5p3k3v822) - autologous cultured chondrocytes 1.2e+007