A Japanese Ministry of Health, the panel Labour and Social Affairs has agreed a plan to carry out what would be the early clinical trials of the world involving induced pluripotent stem (iPS) cells. Acceptance opens the way for an official green light from the Ministry, which could come in early July.
The researchers from RIKEN Center Developmental Biology in Kobe plan to generate replacement pigment epithelial retinal cells from iPS cells generated from patients with macular degeneration. Research is ongoing for several years and was widely reported at conferences.
Approval for clinical trials was expected to be routine. However, the health ministry committee has cited security concerns to put off a decision at the end of May. Japanese media reported that the group meets again today and accepted additional data submitted by RIKEN. Formal approval will be up to the Ministry. RIKEN could begin recruiting patients aware of this year.
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