A subcommittee of the health ministry’s Health Sciences Council approved plans Friday for what would be the world’s first clinical trial using induced pluripotent stem cells.
The health minister is expected shortly to give the final approval for the iPS cell clinical trial on eye disease patients planned by a team from the state-affiliated research institute Riken’s Center for Developmental Biology in Kobe.
The Riken project has already been approved by a screening panel under the subcommittee, as well as by the ethics board of the research institute.
Friday’s meeting of the subcommittee was open to the public. It was the first open screening session for the clinical research application.
The Riken team, led by Masayo Takahashi, plans to make iPS cells, capable of developing into any tissues, from cells taken from sufferers of the wet form of age-related macular degeneration, turn the iPS cells into pigment epithelial cells and transplant the cells into the sufferers’ subretinal regions.
At the meeting, Ryozo Nagai, who chairs the screening panel, reported that the panel has extensively discussed safety risks at the stages of creating iPS and pigment epithelial cells as well as the possible cancer and virus threats.
The panel asked the Riken team to submit a report on the entire genomes of the iPS cell-based cells before transplants so the panel can judge whether there are cancer risks, Nagai said, adding the group was also advised to consult with cancer experts.
For the trial, the team will pick six subjects who meet specific requirements, including having experienced no improvement in their vision with conventional medicine. It aims to conduct the first transplant next summer and spend more than four years examining the results.