Lessons for reviewing clinical trials using induced pluripotent stem cells: examining the case of a first-in-human trial for age-related macular degeneration
In this commentary from Regenerative Medicine, learn more about the pilot first-in-human study conducted by Masayo Takahashi, RIKEN (Japan).
In 2014, Dr Masayo Takahashi (RIKEN, Kobe, Japan) and her research team conducted the first-in-human (FIH) trial using induced pluripotent stem cells (iPSCs). In this pilot case, a sheet of retinal pigment epithelial cells was transplanted into a patient. Along with the ambition of the Japanese government, which sought to dominate the global field of regenerative medicine, the news of this trial attracted great attention to diverse communities such as patients, the general public and stem cell researchers. This mounting excitement about regenerative medicine as a ‘dream therapy’, however, put the five committees reviewing the iPSC-FIH trial under significant stress during the review process from 2012-2013.
"There was no doubt that each review committee experienced extreme pressure to grant an approval"
In this Regenerative Medicine commentary, the minutes of the iPSC-FIH trial review committee meetings were examined to identify future lessons for the committees reviewing cutting-edge FIH trials using novel stem cells.
Takashima K, Inoue Y, Tashiro S, Muto K. Lessons for reviewing clinical trials using induced pluripotent stem cells: examining the case of a first-in-human trial for age-related macular degeneration. Regen. Med. (2018)(Epub ahead of print)