title: Challenges in the evaluation of safety and efficacy of human tissue and cell based products.
abstract: Human tissue and cell-based therapeutic interventions provide efficacious alternative treatment where traditional drugs or medical devices have proved unsatisfactory. Yet human tissue and cell-based products (HTC/P) still present a series of challenges regarding their safety and efficacy. By reviewing the history of development and current regulatory standards and observing activities related to the manufacture of HTC/P, we have described the common characteristics of HTC/P, including the risk of pathogen transmission, transportation methods of human tissues, quality control in HTC/P manufacturing, and the concern of ancillary materials. The ethical issues of cadaveric donation and clinical trial standards for HTC/P have also been discussed. Overall, we have provided a general standard, which articulates the essential requirements on the safety and efficacy of HTC/P.
authors.affiliation: School of Surgery and Pathology, University of Western Australia, QEII Medical Centre, Perth, Western Australia, Australia. minghao.zheng@uwa.edu.au
authors.forename: Ming H
authors.initials: MH
authors.lastname: Zheng
authors.forename: Richard
authors.initials: R
authors.lastname: Pembrey
authors.forename: Silvana
authors.initials: S
authors.lastname: Niutta
authors.forename: Patricia
authors.initials: P
authors.lastname: Stewart-Richardson
authors.forename: Albert
authors.initials: A
authors.lastname: Farrugia
mesh_terms: D017690:Cell Transplantation / Q000009:adverse effects / Q000592:standards; D003141:Communicable Diseases / Q000209:etiology; D006801:Humans; D012449:Safety; D016378:Tissue Transplantation / Q000009:adverse effects / Q000592:standards