title: Comparison of international guidelines for regenerative medicine: Knee cartilage repair and replacement using human-derived cells and tissues.
abstract: Regenerative medicine (RM) is an emerging field using human-derived cells and tissues (HCT). Due to the complexity and diversity of HCT products, each country has its own regulations for authorization and no common method has been applied to date. Individual regulations were previously clarified at the level of statutes but no direct comparison has been reported at the level of guidelines. Here, we generated a new analytical framework that allows comparison of guidelines independent from local definitions of RM, using 2 indicators, product type and information type. The guidelines for products for repair and replacement of knee cartilage in Japan, the United States of America, and Europe were compared and differences were detected in both product type and information type by the proposed analytical framework. Those findings will be critical not only for the product developers to determine the region to initiate the clinical trials but also for the regulators to assess and build their regulations. This analytical framework is potentially expandable to other RM guidelines to identify gaps, leading to trigger discussion of global harmonization in RM regulations.
authors.affiliation: Graduate School of Frontier Science, The University of Tokyo, Japan. Electronic address: kk137360@mgs.k.u-tokyo.ac.jp.
authors.forename: Kuni
authors.initials: K
authors.lastname: Itoh
authors.affiliation: Graduate School of Frontier Science, The University of Tokyo, Japan.
authors.forename: Shingo
authors.initials: S
authors.lastname: Kano
mesh_terms: D019645:Arthroplasty, Replacement, Knee / Q000379:methods*; D002358:Cartilage, Articular / Q000601:surgery*; D064987:Cell- and Tissue-Based Therapy / Q000379:methods*; D005060:Europe; D006801:Humans; D007564:Japan; D007718:Knee Injuries / Q000601:surgery* / Q000628:therapy; D017410:Practice Guidelines as Topic; D044968:Regenerative Medicine / Q000379:methods*; D014481:United States
keywords: EMA; FDA; Guideline; Harmonization; PMDA; Regenerative medicine