Autologous Cultured Chondrocytes: Adverse Events Reported to the United States Food and Drug Administration

Abstract

The most common adverse events reported in association with the Carticel technique involved graft failure, delamination, and tissue hypertrophy.

Tissue Engineering in Orthopaedics

“…Cell monotherapy for the treatment of cartilage defects is more common than in other orthopaedic pathologies. In fact, autologous expanded chondrocytes are part of a product regulated by the FDA and approved for the repair of symptomatic cartilage defects (Carticel; Vericel) 70 . Despite the popularity of these monotherapies, the optimal amount of MSCs required for efficacy is unclear.…”

Cartilage Regeneration

“…While this procedure decreases pain and swelling for limited-size lesions, there is associated donor site morbidity from harvesting the periosteum and chondrocytes. 3 The second-generation ACI technique is an improvement, since a collagen membrane is used instead of periosteum to cover the lesion and prevents compromise to other regions of bone or cartilage. This technique is also known as collagencovered ACI (CACI).…”

Recent Advances in Egypt for Treatment of Talar Osteochondral Lesions

“…Disadvantages of first-generation ACI included donor site morbidity to the knee articular surface and periosteum harvest site, requirement of 2 surgeries, nonarthroscopic nature of the second-stage arthrotomy, damage to the edges of the OCL from suturing the periosteal flap, uneven distribution of the cell suspension within the defect, potential cell leakage, periosteal graft delamination, and hypertrophy. 31 To avoid these limitations, second-generation ACI was introduced. This procedure involved seeding the cultured chondrocytes on various scaffolds in vitro before the second-stage implantation to ensure homogenous cellular distribution on implantation in the OCL, together with easier fixation on the scaffold to the base of the cartilaginous defect by fibrin glue in a dry, all-arthroscopic technique.…”