April 21, 2025

Approval for world’s first iPS cell clinical trial with humans

A Japanese research group will shortly begin the world’s first clinical study using induced pluripotent stem cells.

A Japanese research group will shortly begin the world’s first clinical study using induced pluripotent stem cells (iPS). The researchers received their final approval on the first of August, after months of committee reviews and assessments. 

The group, from RIKEN Center for Developmental Biology in Kobe, will be using retinal pigment epithelium cells, derived from iPS cells, in an attempt to stop macular degeneration. Six patients are to receive a graft in a single eye. Researchers will track the effect of the graft over a period of three years.

Some experts have expressed reservations about the study. Robert Lanza of Advanced Cell Technology (ACT) California, is concerned about the possibility of the cells becoming cancerous. “I cannot imagine any regulatory agency permitting such a trial without years of extensive pre-clinical testing”.

As Nature reported, “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”. 

Xavier Symons
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