Mesenchymal stem cells have potential for effective treatments in various disease areas, such as cardiovascular diseases, central nervous system diseases, autoimmune disorders, gastrointestinal diseases, and respiratory diseases, and are increasingly developed and put to practical use around the world. We will work on the expansion of our development pipeline, beginning at systemic sclerosis and infertility, for which no effective treatment is available.

It is estimated that systemic sclerosis affects approximately 20,000 people in Japan. Systemic sclerosis is an autoimmune disorder that is characterized by hardening of the skin or visceral organs due to fibrosis and is common in women in their 30s to 50s. When symptoms involving the lungs, kidneys, or heart rapidly progress, the disorder may be fatal; however, no curative treatment is available.

Mesenchymal stem cells may treat systemic sclerosis with a combination of effects, such as an inhibitory effect on an abnormal immune response to autologous tissues and the effect of mitigating the fibrosis of hardened tissues by increasing regulatory T cells. Systemic sclerosis will be a target disease for industry-initiated clinical trials for the development of cell therapy and gene therapy products.

It is estimated that infertility of uterine origin accounts for approximately 20% of all cases of infertility. Among them, no effective treatment is available for endometrial growth restriction. Although the growth and thickening of the endometrium are important for implantation of fertilized ova and establishment of pregnancy, reduced blood flow in the endometrium precludes adequate thickening of the endometrium.

Mesenchymal stem cells are expected to improve ischemic conditions as they express the angiogenic factor VEGF. We currently proceed with preparations for the initiation of clinical development of intrauterine- administered mesenchymal stem cells in collaboration with universities. The endometrial growth restriction is planned to be a target disease for Class I clinical research under the Act on the Safety of Regenerative Medicine.