A team led by Kohji Nishida, professor of ophthalmology at Osaka University, expects to conduct its first transplant as early as June.
Four patients with corneal epithelial stem cell impoverishment syndrome will be the subjects of the team’s clinical study, which will focus on safety.
The cause of the syndrome is a loss of stem cells that produce a new cornea that can cover the surface of a black eye caused by injury or other reasons.
The syndrome leads to poor eyesight and sometimes blindness.
Corneas of dead people are currently transplanted into patients, but the organs are chronically in short supply.
In the clinical study, the team will transform iPS cells from a third party into cornea cells, turn them into a “sheet” that is 0.05 millimeter thick, and transplant them onto a patient’s eye.
Three million to 4 million cells will be transplanted in the study, according to the plan.
If all goes well, the transplanted cells will enable a lasting production of cornea cells, maintain corneal transparency, and help the patient regain lost eyesight.
The approval was given under certain conditions.
The ministry panel has required the team to compile an interim report for the panel six months after conducting the second transplant operation. The team can then perform the remaining two transplants.
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