title: Evaluation of the Surgical Device and Procedure for Extracellular Matrix-Scaffold-Supported Human iPSC-Derived Retinal Pigment Epithelium Cell Sheet Transplantation.
abstract: To develop a clinically applicable transplantation device and surgical procedure for extracellular matrix-scaffold-supported human-induced pluripotent stem cell-derived retinal pigment epithelium (hiPSC-RPE) cell sheet transplantation for clinical use.
  
  
  
  The developed surgical device consisted of a custom-designed hand piece and a cannula. The subretinal transplantation of hiPSC-RPE cell sheets was performed in 12 rabbits. The results evaluated were the graft condition (damage or fold), side (front or back), position (center, near, far), and direction (anterior, posterior, right, left) immediately after surgery and the graft condition (shrinking or fold) 2 weeks after surgery. These results were evaluated by fundus photography and optical coherence tomography, followed by immersion-fixed histology.
  
  
  
  All grafts could be transplanted without obvious damage. The transplanted grafts included 2 of 12 folded grafts, 12 of 12 front side, 12 of 12 center position, 10 of 12 anterior direction, and 2 of 12 right direction immediately after surgery, whereas transplantation with a distance between an inlet and an outlet greater than graft and the coaxial direction of the flow paths and the insertion device posed the correct condition and direction. Two weeks after the surgery, the transplanted grafts included two folded grafts and four shrunken grafts; however, complete drainage of subretinal fluid for adhesion between the graft and the host prevented shrunken grafts.
  
  
  
  A developed surgical device and procedure allow grafts to be transplanted into the targeted transplantation site safely and reproducibly. This surgical method will provide additional information on the advancement of future RPE transplantation therapies.
authors.affiliation: Laboratory for Retinal Regeneration, RIKEN Center for Developmental Biology, Chuo-ku, Kobe, Hyogo, Japan 2Department of Ophthalmology, Kawasaki Medical School, Kurashiki, Okayama, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Kamao
authors.affiliation: Laboratory for Retinal Regeneration, RIKEN Center for Developmental Biology, Chuo-ku, Kobe, Hyogo, Japan.
authors.forename: Michiko
authors.initials: M
authors.lastname: Mandai
authors.affiliation: Japan Animal Care Corporation, Meguro, Tokyo, Japan.
authors.forename: Wataru
authors.initials: W
authors.lastname: Ohashi
authors.affiliation: Institute of Biomedical Research and Innovation Hospital, Chuo-ku, Kobe, Hyogo, Japan.
authors.forename: Yasuhiko
authors.initials: Y
authors.lastname: Hirami
authors.affiliation: Institute of Biomedical Research and Innovation Hospital, Chuo-ku, Kobe, Hyogo, Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Kurimoto
authors.affiliation: Department of Ophthalmology, Kawasaki Medical School, Kurashiki, Okayama, Japan.
authors.forename: Junichi
authors.initials: J
authors.lastname: Kiryu
authors.affiliation: Laboratory for Retinal Regeneration, RIKEN Center for Developmental Biology, Chuo-ku, Kobe, Hyogo, Japan.
authors.forename: Masayo
authors.initials: M
authors.lastname: Takahashi
mesh_terms: D000818:Animals; D002460:Cell Line; D017690:Cell Transplantation / Q000295:instrumentation*; D004195:Disease Models, Animal; D004867:Equipment Design; D005109:Extracellular Matrix; D006801:Humans; D057026:Induced Pluripotent Stem Cells; D008268:Macular Degeneration / Q000473:pathology / Q000601:surgery*; D011817:Rabbits; D012164:Retinal Diseases / Q000175:diagnosis / Q000601:surgery*; D055213:Retinal Pigment Epithelium / Q000166:cytology* / Q000637:transplantation; D054457:Tissue Scaffolds; D041623:Tomography, Optical Coherence; D014182:Transplantation, Autologous