Japan Govt OKs Transplants of iPS-Made Corneal Cells

Tokyo, March 5 (Jiji Press)--A team of Osaka University researchers received approval in principle on Tuesday from a Japanese health ministry panel for the world's first clinical study plan to treat patients with damaged corneas by transplanting cells produced from induced pluripotent stem, or iPS, cells from other people. The team will carry out the first transplant as early as July. Kyoto University will provide iPS cells from healthy people to the team, including Prof. Koji Nishida. The team will create sheeted corneal cells about 0.05 millimeter thick from iPS cells and transplant them into patients with serious symptoms of a disease called corneal epithelial stem cell deficiency. It will examine the safety and effect of the transplant for one year. In the study, four patients aged 20 years or older will receive a transplant of some three million to four million corneal cells each, almost the same amount of corneal cells that are in the eyes of healthy people. The transplanted cells are expected to keep making corneal cells and contribute to the recovery of sight. Conventional corneal transplant operations are prone to cause rejection reactions as immune cells contained in corneas are implanted together. As sheeted corneal cells to be used in the study do not contain immune cells, the team believes that they are unlikely to trigger rejection reactions. If the study ends in success, the team will aim to start clinical trials to pave the way for the manufacture and sale of regenerative medical products using the technology and win state approval for them in five or six years. In corneal epithelial stem cell deficiency patients, stem cells that produce corneas are lost because of damage to the cornea due to injury or disease. The loss of corneal stem cells erodes the transparency of the cornea, leading to a drop in visual acuity and possible blindness. The number of patients with severe symptoms of the disease is estimated at hundreds a year. Government-affiliated institute Riken carried out the world's first clinical study for transplanting iPS-made retina cells into an eye disease patient in 2014. Clinical trials have been approved by the Japanese government for transplanting iPS cells into patients with a heart disease, Parkinson's disease and those suffering from blood disease and spinal cord injury. END