Although there are key players in multiple geographies worldwide, Japan has positioned itself as a hub for induced pluripotent stem cell (iPS cell) technology. iPS cells are made by reprogramming adult cells back into an embryonic-like state. Derived from skin or blood cells, they are not controversial.
On 16 May, Nature News reported that “Japan’s health ministry gave doctors at Osaka University permission to take sheets of tissue derived from iPS cells and graft them onto diseased human hearts.” The team of Japanese doctors, led by cardiac surgeon Yoshiki Sawa at Osaka University, will use iPS cells to “create a sheet of 100 million heart-muscle cells.”
From preclinical studies in pigs, the team determined that thin sheets of cell grafts can improve heart function, likely through paracrine signalling. Paracrine signalling is a type of cell-to-cell communication through which cells “talk” to one another, often regulating inflammation, fibrosis (scarring), and and cellular recovery.
While the treatment will only be tested in three patients, a follow-up trial could enroll ten or more patients. Under Japan’s accelerated regulatory pathway for regenerative medicines (cell, gene and tissue products), Dr. Sawa’s iPS cell therapy could be conditionally marketed to the public if a follow-up trial demonstrated safety and an initial proof of efficacy.
Launched in late 2014, Japan’s fast-track system allows for regenerative therapies to receive conditional marketing authorization for up to 7 years, following confirmation of safety and an initial proof of efficacy in Japan in diseases that are serious and have a high unmet need. [Read more…]
Kyoto University has announced that it will start providing human embryonic stem cells (ES cells) by July 2018 to universities and companies within Japan for clinical trial applications. This is a world-first, as most countries have been hesitant to support wide-spread production and distribution of this controversial cell type.
Previously Japan limited the use of human embryonic stem cells to basic research, because the cells are produced from human embryos, making them a highly controversial cell type. In 2014, the Japanese government revised it guidelines, making possible the use human ES cells in clinical studies, as well as laboratory research. [Read more…]
In late 2014, Japan passed two new laws that revolutionized the commercialization of cell therapies within the country by providing an accelerated pathway for product approvals. While there has been much discussion about these laws, few people have a clear understanding of the implications of these regulations on a global scale.
Below, we summarize the laws, identify their importance, and most importantly, speak to how Japan has become a “gateway country” for regenerative medicines. [Read more…]
Have you heard of the recent regulatory changes surrounding cell and gene therapy (CGT) products in Japan?
These changes have greatly increased the interest in taking CGT clinical programs to Japan from development through commercialization. ISCT (International Society for Cellular Therapy) and FIRM (Forum for Innovative Regenerative Medicine) have created a partnership to facilitate the entry and development of future CGT products in Japan.
Robert Preti, PhD (General Manager of Hitachi Chemical’s Regenerative Medicine Business Sector) and Kazuchika Furuishi, PhD (Deputy General Manager) are joining a leading Japanese management consultant (Colin Novick) to discuss the challenges to consider and examples of solutions for successfully taking your clinical cell or gene therapy program to Japan.
On Wednesday, December 6, the webinar will explore the attractive regulatory changes in Japan, as well as:
- Increased offshore filing activity
- Challenges to consider
- Successful CGT programs brought to Japan