title: Validation of a quality assurance program for autologous cultured chondrocyte implantation.
abstract: The use of living human cells to facilitate repair of defects in structural tissues is a rapidly emerging treatment option. A quality assurance program based on U.S. Food and Drug Administration good manufacturing practice regulations and other guidance was established and implemented in a program to use autologous cultured chondrocytes for repair of articular defects of the knee. The development of ex vivo cell therapies presents novel issues of quality assurance. The implementation and evaluation of this quality program was based on the implantation of 303 patients with autologous cultured chondrocytes, in which we analyzed a number of quantifiable parameters and which meets the unique challenges of autologous cell therapy within a rigorous regulatory framework. Application of well-accepted principles of quality assurance and quality control coupled with a thorough understanding of the cell culturing processes will result in a safe and efficacious cell therapy product.
authors.affiliation: Departments of Quality Systems and Manufacturing, Genzyme Tissue Repair, Cambridge, Massachusetts 02139-4136, USA.
authors.forename: T A
authors.initials: TA
authors.lastname: Mayhew
authors.forename: G R
authors.initials: GR
authors.lastname: Williams
authors.forename: M A
authors.initials: MA
authors.lastname: Senica
authors.forename: G
authors.initials: G
authors.lastname: Kuniholm
authors.forename: G C
authors.initials: GC
authors.lastname: Du Moulin
mesh_terms: D002358:Cartilage, Articular / Q000166:cytology*; D002455:Cell Division; D017690:Cell Transplantation / Q000592:standards*; D002478:Cells, Cultured / Q000637:transplantation; D004203:Disinfection; D005270:Femur Head; D005500:Follow-Up Studies; D005568:Forms and Records Control / Q000592:standards; D006801:Humans; D008033:Limulus Test; D008592:Menisci, Tibial / Q000601:surgery*; D017410:Practice Guidelines as Topic; D015397:Program Evaluation; D011785:Quality Assurance, Health Care; D012042:Registries; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration