Posted on behalf of David Cyranoski.
On 1 August, researchers at the RIKEN Center for Developmental Biology in Kobe, Japan, will start recruiting patients for the world’s first clinical study using induced pluripotent stem (iPS) cells.
RIKEN’s endorsement, officially announced today, was the final stage in a long series of regulatory steps that included approval from the health ministry.
Ophthalmologist Masayo Takahashi will be using sheets of retinal pigment epithelium cells, derived from iPS cells, to try to halt the progression of age-related macular degeneration. In the wet-type AMD targeted by Takahashi, abnormal vascularization invades and destabilizes the epithelium, which supports the photoreceptors, and causes loss of vision.
The iPS cells will be genetically identical to each patient’s cells and thus, it is hoped, will avoid problems with immune rejection that hampered past attempts to use fetal-derived cells.
Each of six patients will receive a graft in a single affected eye. The process will be time consuming: deriving the iPS cells and preparing the sheets will take ten months. Progress of the treatments, which will be staggered by eight weeks per patient, will be tracked for three years.
The clinical study is different from a clinical trial and will not, even if successful, open the door for widespread clinical use. But researchers hope it will show enough efficacy to encourage formal clinical trials.