A Japan Ministry of Health, Labour and Welfare panel has accepted a plan to carry out what would be the world's first clinical trials involving induced pluripotent stem (iPS) cells. The acceptance paves the way for an official green light from the ministry, which could come in early July.
Researchers at the RIKEN Center for Developmental Biology in Kobe plan to generate replacement retinal pigment epithelial cells from iPS cells generated from patients suffering age-related macular degeneration. The research has been under way for several years and was widely reported at conferences.
Approval for clinical trials was expected to be routine. However, the health ministry panel cited safety concerns in putting off a decision in late May. Japanese media reported that the panel met again today and accepted additional data submitted by RIKEN. Formal approval will be up to the ministry. RIKEN could start recruiting patients sometime this year.